PROLENE P3DPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031047501), received between Mar 14, 2019 and Feb 26, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6)2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21475377 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21044644 ↗
• InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 TO REMOVE A PAINFUL MASS DURING WHICH THE SURGEON NOTED THE MASS HAD THE APPEARANCE OF A BALLED UP PIECED OF MESH AND THAT THE MASS WAS LIKELY THE PORTION OF MESH OVERLAPPING THE PUBIC TUBERCLE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN IN HER LEFT GROIN. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 10181683 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017 DURING WHICH THE SURGEON NOTED A LOOP OF SMALL BOWEL WAS DENSELY ADHERENT TO THE DEVICE. THE SURGEON WAS UNABLE TO FREE THE MESH FROM THE BOWEL AND WAS FORCED TO PERFORM A SMALL BOWEL RESECTION TO REMOVE THE MESH IN ITS ENTIRETY. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 9545877 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2003 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, LONG-TERM INFECTION, FISTULA, ABSCESS, SCARING, DRAINAGE, EMBARRASSMENT, STRESS AND ANXIETY. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Inflammation; Not Applicable; Pain

  MAUDE report 8421810 ↗