ETHICON PHYSIOMESH PHY2535VRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031132368), received between Jun 24, 2021 and Oct 13, 2024 — classified as 11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 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 A HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023 DURING WHICH THE SURGEON NOTED HE TOOK DOWN THE ENTEROCUTANEOUS FISTULA, SPENT SIGNIFICANT TIME LYSING ADHESIONS, RESECTED THREE PORTIONS OF THE SMALL BOWEL, REMOVED THE INFECTED MESH AND PERFORMED AN ABDOMINAL WALL RECONSTRUCTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, INFECTION AND BOWEL RESECTION. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Pain; Unspecified Infection

  MAUDE report 20436516 ↗
• InjuryOct 13, 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 A HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023 DURING WHICH THE SURGEON NOTED HE TOOK DOWN THE ENTEROCUTANEOUS FISTULA, SPENT SIGNIFICANT TIME LYSING ADHESIONS, RESECTED THREE PORTIONS OF THE SMALL BOWEL, REMOVED THE INFECTED MESH AND PERFORMED AN ABDOMINAL WALL RECONSTRUCTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, INFECTION AND BOWEL RESECTION. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Inflammation; Pain; Unspecified Infection

  MAUDE report 20436514 ↗
• InjuryOct 1, 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20341068 ↗
• InjuryAug 28, 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 ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. IT WAS REPORTED THAT PATIENT HAD HERNIA SURGERY LAST (B)(6) 2009 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 20085246 ↗
• InjuryAug 28, 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 ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. IT WAS REPORTED THAT PATIENT HAD HERNIA SURGERY LAST (B)(6) 2009 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 20085245 ↗
• InjuryAug 27, 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 ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. IT WAS REPORTED THAT PATIENT HAD HERNIA SURGERY LAST (B)(6) 2009 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s)

  MAUDE report 20076537 ↗
• InjuryMay 16, 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DUE TO ABDOMINAL WALL ABSCESS AND PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess; Pain

  MAUDE report 19337873 ↗
• InjuryMay 16, 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 DUE TO CHRONIC ABDOMINAL WOUND AND SCAR TISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Impaired Healing; Scar Tissue

  MAUDE report 19337872 ↗
• InjuryJul 21, 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 A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015 AND (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND OTHER UNDISCLOSED ADVERSE EVENTS. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Diarrhea; Inflammation; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 15081041 ↗
• InjuryJul 21, 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 A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2015 AND (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND OTHER UNDISCLOSED ADVERSE EVENTS. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Diarrhea; Inflammation; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 15081040 ↗
• InjuryJun 24, 2021Adverse 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12064245 ↗