Device brand name · Pelvitex mesh

Parietex Ugytex Pp 15x10cm X1: medical device reports filed with FDA

270 reports name it, 2011–2016. Manufacturer given most often on reports: Sofradim Production. Product code FTL.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

270
device reports naming the brand: 0% of all MAUDE reports · about 18 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 0.7%
classified as malfunction: 2.5% across the product code; 0.4%
classified as death, as reported: 1 reports · not verified by FDA

FDA's MAUDE database holds 270 reports that name the brand "Parietex Ugytex Pp 15x10cm X1" (pelvitex mesh), received between May 2011 and November 2016; the manufacturer given most often on reports is Sofradim Production. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (98.1%), malfunction (0.7%) and death (0.4%); across all mesh, surgical, polymeric reports (product code FTL) death is recorded in 0.5% and malfunction in 2.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are insufficient device problem information (54.8%), device operates differently than expected (15.9%) and defective device (2.6%). The patient problems coded most often are injury, pain and prolapse. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Parietex Ugytex Pp 15x10cm X1 was received in the five years to August 2026; the latest was received in November 2016.

By year received

Event type and report source

Event type, as classified on the report

Death0.4%1

Injury98.1%265

Malfunction0.7%2

Other0%0

Not given0.7%2

Who filed the report

Manufacturer report99.6%269

Voluntary report0%0

User facility report0%0

Distributor report0.4%1

Not given0%0

Grey bar: all 170,304 reports carrying product code FTL. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Insufficient device problem information	148	54.8%	26.3%
Device operates differently than expectedthe device behaved unexpectedly	43	15.9%	1.2%
Defective devicethe device was defective	7	2.6%	34.3%
Material erosion	3	1.1%	5.4%
Material integrity problema problem with the device material	3	1.1%	0.6%
Extrusion	1	0.4%	0.8%
Migration or expulsion of device	1	0.4%	4%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Injurya physical injury	191	70.7%
Painpain, site not specified	91	33.7%
Prolapse	33	12.2%
Incontinence	30	11.1%
Disability	24	8.9%
Erosion	23	8.5%
Urinary tract infectionbladder or urinary infection	19	7%
Blood loss	16	5.9%
Abnormal vaginal discharge	13	4.8%
Complaint, ill-defined	13	4.8%
Abdominal painstomach or belly pain	8	3%
Adhesion(s)	8	3%
Constipationconstipation	8	3%
Dysuriapain on passing urine	8	3%
Inflammationinflammation	8	3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Parietex Ugytex Pp 15x10cm X1	Product code FTL	All MAUDE reports
Reports	270	170,304	26,136,888
Share of that pool	—	0.2%	0%
Classified as death, per 1,000 reports	4	5	9
Classified as injury	98.1%	96.5%	36.2%
Classified as malfunction	0.7%	2.5%	62.3%
Filed by the manufacturer	99.6%	97.4%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code FTL

Brand	Reports	Latest 12 months	Classified as death
Bard Flat Mesh	8,299	110	0.5%
PerFix Plug	8,256	167	0.3%
Parietex	6,304	320	1%
Ventralight ST Mesh	5,813	106	0.5%
Obtryx System	6,031	1	0%
Ventralex ST	5,365	101	0.4%
Tension Free Vaginal Tape	9,355	0	0.1%
Mesh Ventralex	4,661	5	0.4%
3DMax	3,971	155	0.1%
ProGrip	3,820	412	0.8%
Proceed Surg Mesh/Multi Lyr	3,199	29	0%
Mesh Sofradim - Parietex Composite Mesh	2,946	16	1.5%
Advantage? System	3,537	13	0%
Ventrio ST	2,751	51	0.7%
Symbotex	2,741	190	1.2%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Parietex Ugytex Pp 15x10cm X1 reports

How many FDA reports name Parietex Ugytex Pp 15x10cm X1?

270 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (98.1%), malfunction (0.7%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (54.8%), device operates differently than expected (15.9%), defective device (2.6%), material erosion (1.1%) and material integrity problem (1.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.6%) and distributor reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Parietex Ugytex Pp 15x10cm X1 was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.