Gentrix® PSMT1620ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00386190001790), received between Aug 21, 2018 and Apr 21, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 3/25/2020, ACELL, INC. "RECIEVED" A MEDWATCH "NOTIFICAFTION" THAT A PATIENT EXPERIENCED AN ABSCESS FOLLOWING A VENTRAL AND INCISIONAL HERNIA REPAIR REINFORCED WITH GENTRIX THICK AND A HYSTERECTOMY ON (B)(6) 2019. THE ORIGINAL SURGERY ON (B)(6) 2019 WAS A DOUBLE PROCEDURE A VENTRAL AND INCISION HERNIA REPAIR AND A HYSTERECTOMY INCLUDING WORK THAT INVOLVED THE PERINEUM WHICH POTENTIALLY CAUSED A CONTAMINATED OPERATIVE FIELD. THE VENTRAL AND INCISION HERNIA REPAIR WAS NECESSARY DUE TO A PRIOR SURGERY CONDUCTED SOME TIME IN 2006. THE 2006 SURGERY WAS FOR AN INTERNAL HERNIA THAT CAUSED BOWEL OBSTRUCTION, SPECIFICALLY IT WAS A LEFT PARADUODENAL HERNIA AT THE JD JUNCTION THAT CAUSED THE BOWEL OBSTRUCTION. THERE WAS A TEAR IN MESENTERY OF THE SMALL BOWEL. DURING THE SURGERY, ADHESION WERE DISCOVERED ; HOWEVER THE PATIENT HAD NO PRIOR SURGERY BEFORE THIS PROCEDURE IN 2006. ADDITIONAL, HERNIAS DEVELOPED AS A RESULT OF THIS SURGERY IN 2006. THE (B)(6) 2019 SURGERY WAS CONDUCTED VIA A MIDLINE INCISION FROM THE BREAST BONE TO THE PUBIS. AN ANTERIOR ONLAY PATCH OF THE GENTRIX THICK DEVICE WAS PLACED ON THE MUSCLE FASCIA AND SUTURED WITH INTERRUPTED SUTURES. THERE WERE TWO DRAINS PLACED DURING

  Patient problems: Abscess; Fever

  MAUDE report 9982755 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 3/25/2020, ACELL, INC. "RECIEVED" A MEDWATCH "NOTIFICAFTION" THAT A PATIENT EXPERIENCED AN ABSCESS FOLLOWING A VENTRAL AND INCISIONAL HERNIA REPAIR REINFORCED WITH GENTRIX THICK AND A HYSTERECTOMY ON (B)(6) 2019. THE ORIGINAL SURGERY ON (B)(6) 2019 WAS A DOUBLE PROCEDURE A VENTRAL AND INCISION HERNIA REPAIR AND A HYSTERECTOMY INCLUDING WORK THAT INVOLVED THE PERINEUM WHICH POTENTIALLY CAUSED A CONTAMINATED OPERATIVE FIELD. THE VENTRAL AND INCISION HERNIA REPAIR WAS NECESSARY DUE TO A PRIOR SURGERY CONDUCTED SOME TIME IN 2006. THE 2006 SURGERY WAS FOR AN INTERNAL HERNIA THAT CAUSED BOWEL OBSTRUCTION, SPECIFICALLY IT WAS A LEFT PARADUODENAL HERNIA AT THE JD JUNCTION THAT CAUSED THE BOWEL OBSTRUCTION. THERE WAS A TEAR IN MESENTERY OF THE SMALL BOWEL. DURING THE SURGERY, ADHESION WERE DISCOVERED ; HOWEVER THE PATIENT HAD NO PRIOR SURGERY BEFORE THIS PROCEDURE IN 2006. ADDITIONAL, HERNIAS DEVELOPED AS A RESULT OF THIS SURGERY IN 2006. THE (B)(6) 2019 SURGERY WAS CONDUCTED VIA A MIDLINE INCISION FROM THE BREAST BONE TO THE PUBIS. AN ANTERIOR ONLAY PATCH OF THE GENTRIX THICK DEVICE WAS PLACED ON THE MUSCLE FASCIA AND SUTURED WITH INTERRUPTED SUTURES. THERE WERE TWO DRAINS PLACED DURING

  Patient problems: Abscess; Fever

  MAUDE report 9982753 ↗
• InjuryAug 21, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  ON (B)(6) 2018, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING THE REINFORCEMENT OF A INCISIONAL HERNIA REPAIR. CONTRARY TO THE DEVICE'S INSTRUCTIONS FOR USE (IFU), THE DEVICE WAS HYDRATED FOR 25 MINUTES AND IN A 100 DEG FAHRENHEIT WARMER. THE IFU SPECIFIES TO HYDRATE THE DEVICE IN A STERILE DISH WITH ROOM TEMPERATURE STERILE SALINE FOR A MINIMUM OF 30 MINUTES AND MAXIMUM 60 MINUTES. THE SURGEON SECURED ONE SIDE OF THE MESH WITH A 1 CTX BRAIDED SUTURE; HOWEVER, WHEN THE SURGEON BEGAN TO SECURE THE OTHER SIDE DOWN, THE SUTURE PULLED THROUGH ON THE INITIALLY SECURED SIDE OF THE DEVICE. THE DEVICE WAS NOT USED. THE SURGEON REQUESTED AND USED A DEVICE FROM A DIFFERENT MANUFACTURER WHICH RESULTED IN A SURGICAL DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7802057 ↗