Gentrix PSMT1620Recalls & reported problems
Acell, Inc. · Surgical Matrix Thick 16 x 20 cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190001530), received between Jun 1, 2018 and Jun 1, 2018 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Seroma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2018, ACELL, INC. BECAME AWARE THAT A PATIENT EXPERIENCED SEROMAS POST OPERATIVE AFTER A VENTRAL HERNIA REPAIR PROCEDURE WITH AN ACELL DEVICE ON (B)(6) 2017. THE SURGERY WAS FOR A RECURRENT HERNIA. PATIENT HAD 3 PRIOR SURGERIES IN 2008, 2011 AND 2014 FOR HERNIA REPAIR WITH OTHER SURGEONS. THERE WAS NO OTHER INFORMATION PROVIDED REGARDING THESE PRIOR SURGURIES. AFTER SURGERY ON (B)(6) 2017, PATIENT INDICATED HAVING SEVERAL DRAINAGE EPISODES POST OPERATIVE. SURGEON CONFIRMED THE PATIENT EXPERIENCED TWO SEROMAS WHILE STILL UNDER HIS CARE AND AFTER THE SECOND DRAINAGE EPISODE THE FLUID WAS CULTURED WITH NO GROWTH OBSERVED. THE SURGEON DESCRIBED THE FLUID AS CLEAR AND STERILE. SURGEON HAS NOT SEEN PATIENT SINCE (B)(6) 2017. PATIENT CONFIRMED DISCONTINUING CARE FROM SURGEON WHO PERFORMED HERNIA REPAIR ON (B)(6) 2017 AND IS CONTINUING CARE WITH ANOTHER UNDISCLOSED PHYSICAN. PATIENT HAS HEALTH ISSUES THAT INCLUDE HYPERTENSION, HIGH CHOLESTEROL, BRONCHIAL ASTHMA AND A HEART MURMUR. PATIENT IS ALSO A SMOKER, WITH A 12 CIGARETTE A DAY HABIT.
Patient problems: Seroma
MAUDE report 7563553 ↗
Other Mesh, surgical, collagen, large abdominal wall defects devices
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- Biodesign G46600Cook Biotech Incorporated · Mesh, surgical, collagen, large abdominal wall defects1 death3 reports
- Biodesign G48216Cook Biotech Incorporated · Mesh, surgical, collagen, large abdominal wall defects2 reports
- Biodesign G36032Cook Biotech Incorporated · Mesh, surgical, collagen, large abdominal wall defects1 death2 reports
- Biodesign G36033Cook Biotech Incorporated · Mesh, surgical, collagen, large abdominal wall defects1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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