Devices › Suture, absorbable, synthetic, polyglycolic acid
Device brand name · Suture absorbable synthetic polyglycolic ac
Unknown Polysorb Suture: medical device reports filed with FDA
173 reports name it, 2003–2026. Manufacturer given most often on reports: Davis & Geck Caribe. Product code GAM.
- 173
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 10
- reports, 12 months to August 2026
- 13 in the 12 months before
- 40.5%
- classified as malfunction
- 76.5% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 173 reports that name the brand "Unknown Polysorb Suture" (suture absorbable synthetic polyglycolic ac), received between January 2003 and July 2026; the manufacturer given most often on reports is Davis & Geck Caribe. Spellings of one product vary from report to report.
10 reports arrived in the 12 months to August 2026, down 23% from 13 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 (59%), malfunction (40.5%) and death (0.6%); across all suture, absorbable, synthetic, polyglycolic acid reports (product code GAM) death is recorded in 0.2% and malfunction in 76.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (18.5%), unraveled material (18.5%) and insufficient device problem information (8.7%). The patient problems coded most often are wound dehiscence, granuloma and abscess. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 56,946 reports carrying product code GAM. 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 |
|---|---|---|---|
| Breakthe device broke | 32 | 18.5% | 36.3% |
| Unraveled material | 32 | 18.5% | 1% |
| Insufficient device problem information | 15 | 8.7% | 1.1% |
| Detachment of device or device componentpart of the device came off | 10 | 5.8% | 16% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 5.2% | 0.4% |
| Patient-device incompatibilitythe device did not suit the patient | 9 | 5.2% | 1.1% |
| Degraded | 4 | 2.3% | 0.1% |
| Product quality problem | 4 | 2.3% | 0.5% |
| Device slipped | 3 | 1.7% | 0.2% |
| Mechanical problema mechanical problem | 2 | 1.2% | 0.2% |
| Patient device interaction problem | 2 | 1.2% | 0.3% |
| Device or device fragments location unknown | 1 | 0.6% | 0.2% |
| Material twisted/bent | 1 | 0.6% | 0.5% |
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 |
|---|---|---|
| Wound dehiscencea wound reopened | 41 | 23.7% |
| Granuloma | 12 | 6.9% |
| Abscessa collection of pus | 8 | 4.6% |
| Post operative wound infection | 8 | 4.6% |
| Impaired healingslow healing | 6 | 3.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 1.2% |
| Foreign body in patientpart of a device left in the patient | 2 | 1.2% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 1.2% |
| Hernia | 2 | 1.2% |
| Hypersensitivity/allergic reaction | 2 | 1.2% |
| Inflammationinflammation | 2 | 1.2% |
| Scarring | 2 | 1.2% |
| Swelling/ edema | 2 | 1.2% |
| Unintended radiation exposure | 2 | 1.2% |
| Discomfortdiscomfort | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Polysorb Suture | Product code GAM | All MAUDE reports |
|---|---|---|---|
| Reports | 173 | 56,946 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 6 | 2 | 9 |
| Classified as injury | 59% | 23% | 36.2% |
| Classified as malfunction | 40.5% | 76.5% | 62.3% |
| Filed by the manufacturer | 100% | 98% | 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 GAM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Polysorb | 5,410 | 1,836 | 0% |
| V-Loc 180 | 3,447 | 678 | 0% |
| Vicryl Polyglactin 910 Suture Unknown Product | 2,373 | 210 | 1.2% |
| Coated VICRYL (polyglactin 910) Suture | 1,930 | 20 | 0.5% |
| Maxon | 1,809 | 309 | 0% |
| Biosyn | 1,681 | 261 | 0% |
| V-Loc 90 | 1,378 | 226 | 0% |
| VICRYL Polyglactin 910 Suture | 1,262 | 74 | 0.1% |
| Vcl+ Ud 27in 5-0 S/A Tf | 1,125 | 158 | 0.1% |
| Coated VICRYL | 978 | 851 | 0% |
| Vicryl Plus Antibacterial Polyglactin 910 Suture | 852 | 0 | 0.1% |
| Coated Vicryl Plus Antibacterial Polyglactin 910 | 724 | 0 | 0% |
| Vcl+ Ud 18in 5-0 S/A P-3 Prm Mp | 518 | 126 | 0% |
| Unknown VLoc Product | 413 | 39 | 3.6% |
| Caprosyn | 399 | 94 | 0% |
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 Unknown Polysorb Suture reports
How many FDA reports name Unknown Polysorb Suture?
173 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 10 in the latest 12 months.
What kinds of events are reported?
injury (59%), malfunction (40.5%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (18.5%), unraveled material (18.5%), insufficient device problem information (8.7%), detachment of device or device component (5.8%) and device operates differently than expected (5.2%). 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 Unknown Polysorb Suture 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.