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
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page