ETHICON PHYSIOMESH OPHY1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031233171), received between Jul 30, 2018 and Nov 29, 2024 — classified as 1 death, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 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) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20810718 ↗
• DeathJan 11, 2023Adverse 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 REPAIR SURGERY ON (B)(6) 2016 AND TWO MESH PRODUCTS WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SMALL BOWEL RESECTION ON (B)(6) 2020 DURING WHICH THE SURGEON NOTED SMALL BOWEL WAS DAMAGED WHEN HE HAD TO REMOVE THOSE AREAS OF SMALL BOWEL THAT HAD BECOME PLASTERED TO THE UNDERSIDE OF THE PRODUCT. ADHESIONS WERE EXTENSIVE WITH LOTS OF SMALL BOWEL PLASTERED TO THE UNDERSIDE OF THE PREVIOUSLY PLACED MESH. IT WAS REPORTED THAT THE PATIENT SUSTAINED AN INFECTION AND ENTEROCUTANEOUS FISTULA FROM THIS SURGERY. IT WAS REPORTED THAT THE PATIENT UNDERWENT SEVERAL ADDITIONAL SURGERIES TO REPAIR A SMALL BOWEL PERFORATION AND THE FISTULA, WHICH REQUIRED ADDITIONAL SMALL BOWEL RESECTION. IT WAS REPORTED THAT THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Fistula; Perforation; Unspecified Infection

  MAUDE report 16142513 ↗
• InjuryOct 23, 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) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, INFLAMMATION, CONSISTENT BULGING FILLED WITH FLUID, RECURRENCE, AND TENDERNESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; Not Applicable; Pain

  MAUDE report 10727859 ↗
• InjuryJul 30, 2018Adverse 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 REPAIR SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7733112 ↗