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ETHICON PHYSIOMESH PHY2030RRecalls & reported problems

Johnson & Johnson International Inc. · Physiomesh Flexible Composite Mesh · Class 2 · Implant

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 10705031132351), received between Jul 13, 2018 and Jul 13, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Adhesion(s)1
  • Hernia1
  • Not Applicable1

Recent adverse event reports

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

  • InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ATTORNEY THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED (20 X 20 PIECE OF MESH) OPERATIVE NOTE WAS PROVIDED WHICH NOTED ¿A LARGE AMOUNT OF OMENTUM WAS TAKEN DOWN FROM THE LEFT LOWER QUADRANT HERNIA SITE.¿ IT WAS REPORTED A SUTURE WAS PLACED AT EACH OF THE FOUR CORNERS OF THE MESH AND WAS THEN INSERTED INTO THE ABDOMEN AND UNROLLED. IT WAS REPORTED THE SURGEON THEN USED A SUTURE PASSER TO PULL THE SUTURES TO THE EXTERIOR SURFACE AND EACH WERE TIED INTO PLACE. THE MESH WAS THEN CIRCUMFERENTIALLY TACKED AROUND THE HERNIA DEFECT TO PROVIDE A GOOD SEAL. IT WAS REPORTED THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2014 AND THE SURGEON NOTED LARGE VENTRAL HERNIA AND HERNIA SAC AND ¿CARE WAS TAKEN TO DISSECT THE ADHESIONS AND HERNIA SAC FREE.¿ THE SKIN AND SUBCUTANEOUS TISSUE WAS FREED FOR APPROXIMATELY 9 CM IN BOTH DIRECTIONS, LATERALLY. MESH WAS SUTURED INTO PLACE IN 4 QUADRANTS AND ¿THEN IN BETWEEN EACH INITIAL TACKING SUTURE, UNTIL THIS WAS WELL SECURED.¿ ADDITIONAL OVERLAY MESH WAS ALSO TACKED OVER THE PRIMARY AND SYNTHETIC MESH REPAIRS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURREN

    Patient problems: Adhesion(s); Hernia; Not Applicable

    MAUDE report 7687556 ↗

Other Mesh, surgical, polymeric devices

All Mesh, surgical, polymeric devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.