Gentrix® PSMT3040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00386190001585), received between Oct 10, 2018 and Nov 13, 2020 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/21/2020, ACELL, INC. WAS NOTIFIED THAT A GENTRIX DEVICE WAS PARTIALLY EXPLANTED DUE A SEROMA. THE GENTRIX DEVICE WAS IMPLANTED ON (B)(6) 2020 DUE TO A RECURRENT INCISIONAL HERNIA; A PRIOR MESH SEPRAMESH WAS REMOVED AT THIS TIME. THE GENTRIX WAS PLACED IN THE RECTO-RECTUS SPACED WITH A DRAIN. PATIENT HAD A PRE-EXISTING INFECTION WHERE THE GENTRIX WAS PLACED. ON (B)(6) 2020 THE PATIENT WAS SHOWN TO HAVE FLUID BUILDING UP ABOVE THE DEVICE, SURGEON REOPERATED AND DEBRIDED AREA AROUND GENTRIX DEVICE. THE MAJORITY OF THE ACELL DEVICE (>90%) REMAINS IN THE RETRORECTUS SPACE AND IS FUNCTIONING AS INTENDED.

  Patient problems: Seroma

  MAUDE report 10836236 ↗
• InjuryOct 10, 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 HAD UNUSUAL DRAINAGE AFTER AN OPEN RETRORECTUS REPAIR WITH TRANSVERSUS ABDOMINIS (TAR) RELEASE WITH AN ACELL DEVICE ON (B)(6) 2018. THE PATIENT HAD NORMAL DRAINAGE POST OPERATIVELY FOR 3 DAYS. A CT SCAN WAS DONE ON (B)(6) 2018, WHICH WAS NORMAL AND THE SURGICAL DRAINS WERE REMOVED. THERE WAS A SUDDEN APPEARANCE OF DARK, ODOROUS, STOOL LIKE DRAINAGE ON (B)(6) 2018. UPON EXPLORATION OF THE DRAINAGE SITE, THE DEVICE, MUSCLE AND PERIOSTEUM WERE FOUND TO BE BATHED IN A PUSS LIKE MATERIAL. THE DRAINAGE WAS CULTURED AND WAS POSITIVE FOR ENTEROCOCCUS AVIUM. THE PATIENT HAS NO OTHER HISTORY OF THIS BACTERIUM. THE DEVICE WAS EXPLANTED ON (B)(6) 2018. THE PATIENT IS DOING FINE AND UNDERGOING THE FOLLOWING TREATMENT EVERY OTHER DAY: ABDOMINAL LAVAGE, I&D, VICRYL COVERING, AND NPWT (ABTHERA). ALL ACELL DEVICES ARE TERMINALLY STERILIZED PRIOR TO DISTRIBUTION.

  Patient problems: Bacterial Infection

  MAUDE report 7953442 ↗