Device brand name · Surgical mesh

Miniarc Sling System: medical device reports filed with FDA

183 reports name it, 2009–2013. Manufacturer given most often on reports: American Medical Systems. 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.

183
device reports naming the brand: 0% of all MAUDE reports · about 11 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 0%
classified as malfunction: 2.5% across the product code; 0.5%
classified as death, as reported: 1 reports · not verified by FDA

183 medical device reports received by FDA name the brand "Miniarc Sling System" (surgical mesh); the manufacturer given most often on reports is American Medical Systems; received from July 2009 to May 2013. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (99.5%) and death (0.5%); 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 (56.8%), device operates differently than expected (14.8%) and extrusion (8.2%). The patient problems coded most often are pain, emotional changes and injury. 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 Miniarc Sling System was received in the five years to August 2026; the latest was received in May 2013.

By year received

Event type and report source

Event type, as classified on the report

Death0.5%1

Injury99.5%182

Malfunction0%0

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%183

Voluntary report0%0

User facility report0%0

Distributor report0%0

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	104	56.8%	26.3%
Device operates differently than expectedthe device behaved unexpectedly	27	14.8%	1.2%
Extrusion	15	8.2%	0.8%
Material erosion	11	6%	5.4%
Corrodedthe device corroded	2	1.1%	0%
Entrapment of device	2	1.1%	0.3%
Patient-device incompatibilitythe device did not suit the patient	2	1.1%	7.2%
Deformation due to compressive stress	1	0.5%	0%
Material too rigid or stiff	1	0.5%	0%
Migration or expulsion of device	1	0.5%	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
Painpain, site not specified	144	78.7%
Emotional changes	126	68.9%
Injurya physical injury	100	54.6%
Disability	73	39.9%
Erosion	42	23%
Incontinence	40	21.9%
Deformity/ disfigurement	25	13.7%
Inflammationinflammation	25	13.7%
Tissue damage	17	9.3%
Hemorrhage/blood loss/bleeding	15	8.2%
Nerve damage	14	7.7%
Scarring	12	6.6%
Abdominal painstomach or belly pain	10	5.5%
Abnormal vaginal discharge	8	4.4%
Dysuriapain on passing urine	8	4.4%

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

In context

Measure	Miniarc Sling System	Product code FTL	All MAUDE reports
Reports	183	170,304	26,136,888
Share of that pool	—	0.1%	0%
Classified as death, per 1,000 reports	5	5	9
Classified as injury	99.5%	96.5%	36.2%
Classified as malfunction	0%	2.5%	62.3%
Filed by the manufacturer	100%	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 Miniarc Sling System reports

How many FDA reports name Miniarc Sling System?

183 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 (99.5%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (56.8%), device operates differently than expected (14.8%), extrusion (8.2%), material erosion (6%) and corroded (1.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Miniarc Sling System 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.