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ETHICON PHYSIOMESH OPHY2536Recalls & reported problems

Johnson & Johnson International Inc. · PHYSIOMESH OPEN LARGE ENVELOPE · Class 2 · Implant

All models of ETHICON PHYSIOMESH (14)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031233201), received between Jan 23, 2018 and Jan 23, 2018 — classified as 1 injury.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Not Applicable1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. THE SURGERY WAS A SUCCESS, EVERYTHING WENT WELL. AFTER A FEW DAYS, THE PATIENT WENT HOME WELL, WITH DRAIN AND WITHOUT MAJOR PROBLEMS. THE PATIENT WAS AT HOME WITH A DRAIN WHEN A BAD SMELL WAS COMING OUT OF THE DRAIN. THE DOCTOR ASKED THE PATIENT TO RETURN TO THE HOSPITAL, AND THE DOCTOR SAW FECES IN THE DRAIN. THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE ON (B)(6) 2017 AND THE SURGEON FOUND THE MESH WAS STRETCHED OUT, IN PERFECT CONDITION ON THE SIDES, ALREADY BEGINNING TO FORM THE WALL. IN THE MIDDLE OF PATIENT¿S BELLY, THE SURGEON FOUND AN INTESTINAL LOOP ADHERED ON THE MESH, ABOUT A COIN SIZE. DUE TO THAT, THE SURGEON REMOVED THE MESH AND LEFT THE PATIENT HERNIATED. ON (B)(6) 2017, THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE. THE SURGEON REPORTED THAT THE PATIENT IS IN VERY SERIOUS CONDITION, AT RISK OF DEATH, HOSPITALIZED AND IN PERITONEOTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Not Applicable

    MAUDE report 7213233 ↗

Other Mesh, surgical, polymeric devices

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Sources and updates

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