PROCEED PVPMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,233 adverse event reports that list this exact device (DI 10705031132405), received between Jun 13, 2018 and Jun 8, 2026 — classified as 1,171 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Migration” (21 reports).

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 25 most recent of 1,233 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR ON (B)(6) 2013 AND MESH AND MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25438377 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25387180 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A REPAIR SUPRAUMBILICAL INCISIONAL HERNIA, VENTRAL ON (B)(6) 2023 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25373850 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FIRM BULGE SUPRAUMBILICAL WITH PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 25372136 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS. NO ADDITIONAL INFORMATION CAN BE ADDED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s)

  MAUDE report 25298411 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INFECTION - FUNGAL. THE PATIENT REPORTED PAIN AND DISCOMFORT. THE PATIENT UNDERWENT RE-OPERATION, A LAPAROTOMY FOR REMOVAL OF MESH. THE PATIENT HAS HAD ONGOING WOUND COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 25151178 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND INFECTION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25034986 ↗
• MalfunctionApr 29, 2026Material Disintegration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND MESH WAS USED. IT WAS REPORTED THAT THE MESH CRUMBLED APART AS SOON AS WE TRIED TO INSERT IT INTO THE PATIENT, AND WE COULDN'T USE IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031311 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SCARRING, DISFIGUREMENT AND CHRONIC PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Deformity/ Disfigurement; Pain; Scar Tissue

  MAUDE report 24925700 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A REPAIR OF INCARCERATED VENTRAL HERNIA ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH AND REPAIR OF INCARCERATED INCISIONAL HERNIA ON (B)(6) 2022. IT WAS REPORTED THE PATIENT EXPERIENCED WORSENING ABDOMINAL PAIN, INTRA-ABDOMINAL ADHESIONS AND ABDOMINAL WALL MASS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Swelling/ Edema

  MAUDE report 24239724 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A REPAIR OF INCARCERATED VENTRAL HERNIA ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY OF PREVIOUSLY PLACED MESH AND REPAIR OF INCARCERATED INCISIONAL HERNIA ON (B)(6) 2022. IT WAS REPORTED THE PATIENT EXPERIENCED WORSENING ABDOMINAL PAIN, INTRA-ABDOMINAL ADHESIONS AND ABDOMINAL WALL MASS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Adhesion(s); Swelling/ Edema

  MAUDE report 24239717 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE 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 24237962 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2011 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24202667 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2017 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24183114 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON AN UNKNOWN DATE AND A MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24182598 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT UMBILICAL HERNIA PROCEDURE ON (B)(6) 2016 AND A MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24168346 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2019 AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING INTOLERABLE ABDOMINAL PAIN SINCE PROSTHESIS PLACEMENT. THESE PAINS LED THE PATIENT TO CONSULT A PAIN CENTER FOR 3 YEARS. THE PATIENT HAD TO BE RE-OPERATED 2 MONTHS AFTER THE IMPLANTATION OF THE PROSTHESIS TO CLEAN THE AREA AND REMOVE THE RESIDUES OF PROSTHESIS. THE AREA WAS TOO INFLAMED TO PUT BACK A PROSTHESIS SO THE PATIENT ONLY HAD SUTURES THAT DROPPED IN THE MONTHS THAT FOLLOWED. SO THE PATIENT HAS AN EVENTRATION CURRENTLY AND STILL PAIN. THE PATIENT SUFFERED THE MARTYR FOR YEARS UNTIL THEY LOST THEIR JOB, COULD NOT MOVE. THE PAINS WERE VERY VIOLENT: IN STABBING, ALSO NEUROPATHIC PAINS WITH ELECTRIC SHOCKS AS SOON AS THE PATIENT MOVED, WITH EACH MOVEMENT. THE PATIENT REGULARLY CONSULTED THE PAIN CENTER. TODAY THE PATIENT REPORTS BEING DISABLED AND LIVE AS IF THEY WERE 90 YEARS OLD. NO FURTHER INFORMATION IS AVAILABLE OR COULD BE OBTAINED AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Inflammation; Pain

  MAUDE report 24154067 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT INCARCERATED UMBILICAL HERNIA REPAIR ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24152314 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24137484 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR AND MESH WAS IMPLANTED ON (B)(6) 2015. IT WAS REPORTED THAT AN UNKNOWN ADVERSE EVENT OCCURRED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24085612 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT RIGHT UMBILICAL VENTRAL HERNIA REPAIR ON (B)(6) 2012 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT UMBILICAL HERNIA REPAIR ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND DISCOMFORT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Abdominal Pain; Discomfort; Hernia

  MAUDE report 24084677 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT RIGHT UMBILICAL VENTRAL HERNIA REPAIR ON (B)(6) 2012 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT UMBILICAL HERNIA REPAIR ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND DISCOMFORT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Abdominal Pain; Discomfort

  MAUDE report 24084676 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24074004 ↗
• InjuryDec 18, 2025Adverse 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 REMOVAL SURGERY AND RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2019 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, LOSS OF APPETITE, STRESS AND ANXIETY. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2017 AND A MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Inflammation; Pain

  MAUDE report 23840414 ↗
• MalfunctionDec 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT IN 2025 MESH PACKAGING WAS NOTED TO BE DAMAGED AND THREW OUT THE CONTAMINATED PRODUCT. THERE WERE NO PATIENT INVOLVEMENT. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783721 ↗