Gentrix® PSM1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190001929), received between Jan 5, 2021 and Jan 5, 2021 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, ACELL, INC. WAS NOTIFIED THAT A PATIENT EXPERIENCED A FEVER AND SEROMA POST IMPLANTATION OF TWO GENTRIX DEVICES. THE GENTRIX DEVICES WERE IMPLANTED ON (B)(6) 2020 FOR A C-SECTION. THE DEVICES WERE PLACED IN THE UTERUS INCISION WITHIN THE MUSCLE AND FASCIA. THE DEVICES WERE CUT DOWN TO A SMALLER SIZE TO ACCOMMODATE THE SMALLER INCISION AND THEN TACKED IN PLACE IN 4 CORNERS. ON (B)(6) 2020, THE PATIENT STATED HAVING A FEVER AND WENT TO THE ER. THE PATIENT WAS ADMITTED, AND WAS SHOWING FLUID IN TWO SPACES FROM THE CAT SCAN. THE PATIENT WAS PLACED ON ANTIBIOTICS DURING THIS VISIT AND WAS DISCHARGED A DAY LATER. THE PATIENT MADE AN ADDITIONAL VISIT TO THE ER ON (B)(6) 2020 FOR A FEVER AND ABDOMINAL PAIN. THE PATIENT WAS GIVEN ANTIBIOTICS DURING THIS VISIT AND DISCHARGED A DAY LATER. THERE WAS NO SURGICAL INTERVENTION TO RESOLVE THE SEROMA FOR BOTH VISITS TO THE ER ON (B)(6) 2020 AND (B)(6) 2020. THE GENTRIX DEVICES REMAINS IN PLACE AND ARE FUNCTIONING AS INTENDED.

  Patient problems: Fever; Seroma

  MAUDE report 11121314 ↗