Suture, nonabsorbable, synthetic, polypropylene: medical device reports filed with FDA

20,028 reports carry this product code, 1992–2026; 30 brands with a page.

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.

20,028
reports with this product code: 0.1% of all MAUDE reports; 2,909
reports, 12 months to August 2026: 2,202 in the 12 months before; 80.5%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

Product code GAW is FDA's classification for "Suture, nonabsorbable, synthetic, polypropylene" (general, Plastic Surgery panel), a class 2 device. 20,028 medical device reports carry this product code, 0.1% of the MAUDE database, from August 1992 to August 2026.

2,909 reports arrived in the 12 months to August 2026, up 32% from 2,202 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 malfunction (80.5%), injury (17.9%) and death (1.1%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
PROLENE Polypropylene Suture	1,989	177	3.4%	51.5%
Prolene Polypropylene Suture Unknown Product	1,623	133	2.2%	5.7%
Prolene	746	729	0.3%	94.4%
Surgipro ll	570	37	0.5%	87%
Prlne Blu 36in 5-0 D/A Rb-1	310	97	0.3%	98.1%
Surgipro	284	89	0.9%	23.5%
Gore-Tex Suture	233	16	1.2%	53.5%
Prolene Sut 30in 75cm 6-0 Blu	204	43	0.5%	98%
Prolene Suture 30 75cm 6-0 Blu	199	0	0%	98.5%
Prlne Blu 30in 6-0 D/A C-1	184	29	0%	97.8%
Prolene Blue 0 7m 60cm W/Ndl	170	0	0%	98.8%
Non Absorbable Surgical Suture	167	39	0%	96.4%
Prlne Blu 24in 7-0 D/A Bv-1	157	37	1.9%	98.1%
Prolene Suture 36 90cm 5-0 Blu	156	0	0%	98.7%
Prlne Blu 24in 7-0 D/A Bv175-6 Mp	151	28	0%	100%
Unknown Suture Product	55	28	0.9%	45.3%
Suture Unknown	44	39	0.6%	50.1%
McKesson	22	74	0%	89.7%
PROLENE POLYPROPYLENE Mesh	19	52	0.1%	1.7%
Coated VICRYL (polyglactin 910) Suture	9	20	0.5%	19.4%
ETHIBOND Extra & Excel Polyester Suture	9	34	0%	24.9%
Stratafix	7	647	0.1%	74.8%
ETHILON Nylon Suture	2	9	0.2%	47.6%
Silk Suture	2	35	0%	69.8%
Alcon	1	2	0%	36.7%
Capio	1	13	0%	68.5%
Coated VICRYL	1	851	0%	92.4%
Endo Stitch	1	64	0.1%	79.4%
Maxon	1	309	0%	93.9%
MONOCRYL (poliglecaprone 25) Suture	1	24	0%	24.9%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Ethicon	14,156	70.7%
B Braun Surgical	1,715	8.6%
Davis & Geck Caribe	1,660	8.3%
United States Surgical	379	1.9%
W L Gore & Associates	216	1.1%
Teleflex Medical	96	0.5%
Covidien North Haven	89	0.4%
Alcon Research - Alcon Precision Device	37	0.2%
Covidien Formerly US Surgical A Divison	24	0.1%
Ussc Puerto Rico	23	0.1%
Ponce - Uss	20	0.1%
Ethicon San Angelo	17	0.1%
Covidien Surgical	10	0%
Aesculap	9	0%
Coloplast A/S	8	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.1%226

Injury17.9%3,591

Malfunction80.5%16,131

Other0.2%33

Not given0.2%47

Who filed

Manufacturer report98.4%19,701

Voluntary report0.7%140

User facility report0%0

Distributor report0%6

Not given0.9%181

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	9,121	45.5%
Material separation	4,566	22.8%
Detachment of device or device componentpart of the device came off	1,079	5.4%
Material frayed	939	4.7%
Suture line disruption	377	1.9%
Failure to adhere or bond	374	1.9%
Material split, cut or torn	330	1.6%
Needle, separation	225	1.1%
Material integrity problema problem with the device material	212	1.1%
Replace	191	1%
Detachment of device component	188	0.9%
Other (for use when an appropriate device code cannot be identified)	184	0.9%
Insufficient device problem information	155	0.8%
Device contaminated during manufacture or shipping	140	0.7%
Material twisted/bent	112	0.6%
Device markings/labelling problema problem with the device markings or label	105	0.5%
Suture line separation	100	0.5%
Device operates differently than expectedthe device behaved unexpectedly	94	0.5%
Split	94	0.5%
Explanted	88	0.4%

Questions about suture, nonabsorbable, synthetic, polypropylene reports

What is product code GAW?

FDA's classification code for "Suture, nonabsorbable, synthetic, polypropylene", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

20,028 reports through August 2026, 2,909 of them in the latest 12 months.

Which brands appear most often?

PROLENE Polypropylene Suture (1,989), Prolene Polypropylene Suture Unknown Product (1,623), Prolene (746), Surgipro ll (570) and Prlne Blu 36in 5-0 D/A Rb-1 (310). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.