PROCEED PVPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 622 adverse event reports that list this exact device (DI 10705031132412), received between Nov 21, 2017 and Mar 19, 2026 — classified as 585 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 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 622 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2015 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 24646036 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24192975 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND MESH WAS USED. THE MESH HAS SOME SUTURES; WHEN PULLING OR ADJUSTING, IT BROKE, WHICH CAUSED ANOTHER MESH TO BE REQUESTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523272 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND MESH WAS TO BE USED. THE CUSTOMER WET THE MESH BEFORE USING IT AS HE USUALLY DOES AND IMMEDIATELY AFTERWARDS, BEFORE EVEN POSITIONING IT, IT CRUMPLED. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302801 ↗
• MalfunctionSep 12, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR ON (B)(6) 2025 AND MESH WAS USED. THE SCRUB NURSE HANDED THE MESH TO HIM AND AS SOON AS HE PUSHED IT INSIDE THE ABDOMEN THE MESH COMPLETELY DISINTEGRATED. HE WAS UNABLE TO USE IT AND WE HAD TO REPLACE THE MESH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037765 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22780757 ↗
• InjuryAug 4, 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 INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2014 AND TWO MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AND SMALL-BOWEL OBSTRUCTION. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 22700359 ↗
• InjuryAug 4, 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 INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2014 AND TWO MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AND SMALL-BOWEL OBSTRUCTION. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 22700255 ↗
• InjuryAug 1, 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 HERNIA REPAIR ON (B)(6) 2013 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22687537 ↗
• InjuryJun 3, 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 REPAIR OF UMBILICAL VENTRAL HERNIA ON (B)(6) 2012 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AND REMOVAL SURGERY ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22130202 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2017 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT, LYSIS OF ADHESIONS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Discomfort; Hernia; Pain

  MAUDE report 22085220 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT PATIENT EXPERIENCED INFECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22076132 ↗
• InjuryMay 22, 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 INCISIONAL HERNIA REPAIR ON (B)(6) 2011 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2012 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain

  MAUDE report 22075679 ↗
• InjuryMay 16, 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 HERNIA PROCEDURE ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22036574 ↗
• InjuryMay 15, 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 REVISION SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND ADHESION. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2015 WHICH IS CAPTURED IN SEPARATE FILE. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22026202 ↗
• InjuryMay 15, 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 REVISION SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND ADHESION. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2015 WHICH IS CAPTURED IN SEPARATE FILE. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22025955 ↗
• InjuryMay 15, 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 HERNIA REPAIR SURGERY ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED INFECTION AND PAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22023776 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2014 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR ON (B)(6) 2014. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hernia; Pain

  MAUDE report 22016157 ↗
• InjuryMay 14, 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 REVISION SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22015997 ↗
• InjuryMay 12, 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 HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22001731 ↗
• InjuryMay 12, 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 REVISION SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON 04/11/2011. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESION, SCARRING AND PAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain; Scar Tissue

  MAUDE report 22000828 ↗
• InjuryMay 10, 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 RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR AND A MESH WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21999500 ↗
• InjuryMay 10, 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 RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR AND A MESH WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21999499 ↗
• InjuryMay 7, 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 HERNIA PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21976391 ↗
• InjuryMay 6, 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 OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21967039 ↗