ACell® PFM0505Recalls & reported problems
Acell, Inc. · Pelvic Floor Matrix 5 x 5 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 00386190001264), received between Aug 7, 2018 and Aug 7, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ACELL, INC. BECAME AWARE THAT A CLINICAL STUDY PARTICIPANT IS EXPERIENCING DYSPAREUNIA OR PAIN DURING SEXUAL INTERCOURSE AFTER RECTOCELE REPAIR WITH AN ACELL DEVICE ON (B)(6) 2017. IT IS THE OPINION OF THE SURGEON THAT THE ACELL DEVICE IS POSSIBLY RELATED TO THE ADVERSE EVENT. SURGEON THINKS SCAR TISSUE MAY HAVE FORMED DURING REMODELING OF GRAFT OR IT COULD BE DUE TO THE RECTOCELE REPAIR. THE SITE OF VAGINAL PAIN IS THE ANTERIOR WALL. THE SURGEON HYPOTHESIZES THE CHANGE OF AXIS OF VAGINA PUTS MORE FORCE ON ANTERIOR VAGINAL WALL DUE TO LACK OF FLEXIBILITY IN THE POSTERIOR WALL. PATIENT HAS NOT BEEN TREATED FOR THE DYSPAREUNIA.
Patient problems: Pain
MAUDE report 7757135 ↗
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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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