ETHICON PHYSIOMESH OPHY1215Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031233188), received between Jan 23, 2018 and Oct 17, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Hole In Material” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 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 SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20478016 ↗
• InjuryOct 10, 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 SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20424721 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE THREE YEARS AGO AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT SINCE THE MESH INSERTION, THE PATIENT HAS BEEN DIAGNOSED WITH ALPHA GAL SYNDROME. IT WAS REPORTED THAT THE PATIENT EXPERIENCES ALLERGIC REACTION. IT WAS ALSO REPORTED THAT EVERY TIME THE PATIENT EATS, THE PATIENT GETS ABDOMINAL CRAMPS AND IT'S SO PAINFUL THAT THE PATIENT HAS TO SIT ON THE TOILET IN CASE THE PATIENT HAS DIARRHEA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Diarrhea; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 15386452 ↗
• MalfunctionJan 23, 2018Hole In Material; Hole In Material

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIATAL HERNIA REPAIR ON (B)(6) 2018 AND MESH WAS USED. WHILE THE SURGEON WAS PLACING THE MESH INTO PLACE, TWO SMALL TEARS APPEARED IN THE MIDDLE. THE SURGEON APPLIED AN ADDITIONAL 10X10 MESH OVER THE TORN AREA AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213296 ↗