ETHICON PHYSIOMESH PHY1515QRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031132313), received between May 17, 2021 and Aug 22, 2024 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 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 VENTRAL INCISIONAL HERNIA AND BILATERAL INGUINAL HERNIAS REPAIR ON (B)(6) 2013 AND MESH AND TWO (2) MESH PRODUCTS WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THE PATIENT EXPERIENCED ABDOMINAL PAIN, ADHESION, SCAR TISSUE, CORD LIPOMA AND SMALL INTESTINE LOOP. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 20027991 ↗
• InjuryAug 21, 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 VENTRAL INCISIONAL HERNIA AND BILATERAL INGUINAL HERNIAS REPAIR ON (B)(6) 2013 AND MESH AND TWO (2) MESH PRODUCTS WERE IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THE PATIENT EXPERIENCED ABDOMINAL PAIN, ADHESION, SCAR TISSUE, CORD LIPOMA AND SMALL INTESTINE LOOP. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 20019239 ↗
• InjuryJun 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. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. NO ADDITIONAL INFORMATION CAN BE ADDED.

  Patient problems: Adhesion(s)

  MAUDE report 19554938 ↗
• InjuryMar 18, 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) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Diarrhea; Inflammation; Nausea; Obstruction/Occlusion; Pain

  MAUDE report 18919953 ↗
• InjuryAug 1, 2023Adverse 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 SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING SURGERY THE PATIENT EXPERIENCED PAIN, BURNING, BLOATED WITH FLUID IN HER ABDOMEN, AND BLEEDING FROM RECTUM. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023 DURING WHICH THE SURGEON NOTED THAT THE MESH WAS ADHERED TO THE BOWEL. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Abdominal Distention; Adhesion(s); Burning Sensation; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 17431861 ↗
• InjuryAug 1, 2023Adverse 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 SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT CONTINUES TO EXPERIENCE PAIN, BURNING, BLOATING, CONSTIPATION, INCONTINENCE, OBSTRUCTION IN BOWEL AND URETER, AND UNABLE TO DEFECATE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Constipation; Incontinence; Obstruction/Occlusion; Pain

  MAUDE report 17431859 ↗
• InjuryDec 13, 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 HERNIA REPAIR SURGERY (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2015 DUE TO ADHESION AND RECURRENT INCISIONAL HERNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 15974760 ↗
• InjuryNov 6, 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 HERNIA REPAIR SURGERY (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABSCESS, OBSTRUCTION, INFECTION, SEVERE ABDOMINAL PAIN, ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Obstruction/Occlusion; Unspecified Infection

  MAUDE report 15741417 ↗
• InjuryOct 28, 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 HERNIA REPAIR SURGERY (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, GASTROINTESTINAL MALFUNCTION, GROTESQUE SWELLING, AND HERNIA RECURRENCE, AND ADDITIONAL SURGERY ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15689882 ↗
• InjuryOct 10, 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 AN INCISIONAL HERNIA REPAIR SURGERY (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15570467 ↗
• InjuryAug 30, 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 HERNIA REPAIR SURGERY (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15325316 ↗
• InjuryJan 25, 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 HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13351149 ↗
• InjuryJan 25, 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 HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13351118 ↗
• InjuryMay 17, 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) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON(B)(6) 2017 FOR REPAIR OF AN INCARNATED INCISIONAL HERNIA BY AND THE SURGEON REMOVED THE MESH . 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

  MAUDE report 11838348 ↗