PROLENE PMXSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031049079), received between Aug 5, 2019 and Dec 30, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21044706 ↗
• InjuryDec 3, 2024Adverse 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) /2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20832287 ↗
• InjurySep 23, 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 A HERNIA PROCEDURE ON (B)(6) 2018 AND MESH AND MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021 DURING WHICH THE SURGEON NOTED DENSE ADHESIONS THAT CONSISTED OF THE OMENTUM AND SMALL BOWEL. HE PERFORMED EXTENSIVE LYSIS OF ADHESIONS REMOVED THE MESH. IT WAS REPORTED THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 20288198 ↗
• InjurySep 19, 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 A HERNIA PROCEDURE ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021 DURING WHICH THE SURGEON NOTED DENSE ADHESIONS THAT CONSISTED OF THE OMENTUM AND SMALL BOWEL. HE PERFORMED EXTENSIVE LYSIS OF ADHESIONS REMOVED THE MESH. IT WAS REPORTED THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 20256019 ↗
• InjuryNov 3, 2021Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2015 DUE TO MESH EXPOSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion

  MAUDE report 12746284 ↗
• InjuryJun 7, 2021Adverse 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) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11947113 ↗
• InjuryAug 5, 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 REVISION SURGERY ON (B)(6) 2007 AND TWO (2) MESH PRODUCTS WERE IMPLANTED DURING WHICH THE SURGEON NOTED ¿SCARRING OF THE CONJOINED TENDON IN THE LEFT GROIN AND IT WAS ATTACHED TO THE MESH¿. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERWENT LEFT INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT GROIN PAIN. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 8860812 ↗
• InjuryAug 5, 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 REVISION SURGERY ON (B)(6) 2007 AND TWO (2) MESH PRODUCTS WERE IMPLANTED DURING WHICH THE SURGEON NOTED ¿SCARRING OF THE CONJOINED TENDON IN THE LEFT GROIN AND IT WAS ATTACHED TO THE MESH¿. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERWENT LEFT INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT GROIN PAIN. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 8860806 ↗