ACell® PFM0912Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386190001288), received between Jul 18, 2019 and Jul 18, 2019 — 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.

• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 6/19/2019 ACELL, INC. RECEIVED AN ADVERSE EVENT THROUGH THE (B)(6) REGISTRY FROM OUR (B)(6) POSTMARKET SURVEILLANCE STUDIES ON TRANSVAGINAL PELVIC MESH PLACEMENT FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE (POP). DURING THE EVALUATION OF THE ADVERSE EVENT, WE LEARNED THAT THE PRODUCT SOLYX (BOSTON SCIENTIFIC) WAS ALSO INVOLVED IN THE INCIDENT. THE STUDY SUBJECT IS EXPERIENCING CONTINUING RECURRENT PROLAPSE FOLLOWING PELVIC FLOOR REPAIR WITH AN ACELL'S DEVICE AND BOSTON SCIENTIFIC SOLYX PRODUCT. THE INDEX POP REPAIR PROCEDURE WAS CONDUCTED ON (B)(6) 2018 AND THE ADVERSE EVENT ONSET WAS (B)(6) 2019. ADDITIONAL SURGICAL TREATMENT WAS PERFORMED ON (B)(6) 2019. THERE WAS NO PROCEDURAL COMPLICATION AT THE TIME OF INDEX AND FOLLOW UP SURGERY. THE ACELL DEVICE WAS NOT EXPLANTED.

  Patient problems: Prolapse

  MAUDE report 8803568 ↗