ETHICON PHYSIOMESH OPHY1525Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031233195), received between Feb 7, 2022 and Oct 18, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryOct 18, 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 RECURRENT INCISIONAL HERNIA REPAIR ON (B)(6) 2018 WITH MESH IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONSTIPATION, BLOATING, VOMITING, NAUSEA, NUMBNESS, WEAKNESS, COLDNESS, TINGLING AROUND THE INCISION AREA AND OPENING OF THE SUTURES OR WOUND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Fatigue; Nausea; Numbness; Vomiting

  MAUDE report 20482240 ↗
• InjuryMar 24, 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 AN HERNIA REPAIR SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. IT WAS REPORTED THAT PATIENT EXPERIENCED ADHESION AND OBSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 16608577 ↗
• 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 16142512 ↗
• InjuryFeb 7, 2022Adverse 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) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Obstruction/Occlusion

  MAUDE report 13476757 ↗