ULTRAPRO UMR3 (UDI 10705031132498)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031132498), received between Apr 9, 2018 and Jan 15, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT REVISION SURGERY AND MESH WAS IMPLANTED ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2021 AND TWO MESHES WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24085280 ↗
• 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 PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2009 AND TWO (2) MESH WERE IMPLANTED. IT WAS ALSO PREVIOUSLY REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22687028 ↗
• InjuryJul 8, 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) 2016 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND ADHESION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22453999 ↗
• InjuryAug 10, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THERE WAS INFECTION AFTER FEW MONTHS OF IMPLANTATION AND DURING RE ADMISSION THE SURGEON FOUND THAT MESH WAS SCRAMBLED.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 8881714 ↗
• InjuryAug 8, 2019Adverse 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 INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 8876066 ↗
• InjuryMar 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE MANY BAD SYMPTOMS LONG AFTER THE HERNIA SURGERY AND THE IMPLANTATION OF THE MESH, AND THE PATIENT IS STILL CURRENTLY UNDER THE CARE OF (B)(6). IT WAS REPORTED THAT THE PATIENT'S OVERALL CONDITION CONTINUES TO WORSEN WITH THE IDIOPATHIC SMALL FIBER NEUROPATHY, IDIOPATHIC PROGRESSIVE POLYNEUROPATHY, AND ALL OF THE AUTO-IMMUNE SYMPTOMS HE IS EXPERIENCING. IT WAS REPORTED THAT WITH ALL OF THE EXTENSIVE TESTING THAT MSU HAS PERFORMED AND ADDITIONAL SPECIALIST THAT THE PATIENT HAS BEEN SENT TO, THERE HAS BEEN NO CLEAR INDICATION OF WHAT IS CAUSING ALL OF THIS. IT WAS REPORTED THAT THE ONLY CERTAINTY OF THE PATIENT'S CONDITION IS THAT ALL OF THESE SYMPTOMS BEGAN IMMEDIATELY FOLLOWING THE HERNIA SURGERY AND THE IMPLANTATION OF THE MESH. IT WAS REPORTED THAT IT WAS WHEN ALL OF THE HAIR FELL OUT OF THE PATIENT'S LEGS AND THE INTENSE BURNING PAIN BEGAN IN THE PATIENT'S CALVES AND FOREARMS AND HANDS, LEADING TO A SKIN BIOPSY WITH A DIAGNOSIS OF SMALL FIBER NEUROPATHY, IDIOPATHIC.

  Patient problems: Neuropathy; Pain

  MAUDE report 8385014 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT HAD REMOVAL SURGERY ON (B)(6) 2017 DURING WHICH ¿THE LEFT HALF OF THE HERNIA SAC WAS COMPRISED OF MESH THAT HAD NOT INCORPORATED INTO THE ANTERIOR ABDOMINAL WALL¿ AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, STOMACH CRAMPING, TROUBLE DIGESTING FOOD AND DIFFICULTY REGULATING BOWEL FUNCTIONS. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Cramp(s); No Code Available; Pain

  MAUDE report 8345660 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2017 AND MESH WAS IMPLANTED. ON (B)(6) 2017, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR BROWN LEAKAGE THAT WAS COMING FROM THE SURGERY SITE. THE PATIENT REPORTED THAT A SWAB OR TEST WAS NOT TAKEN TO SEE IF THE PATIENT HAD AN INFECTION. THE PATIENT REPORTED THEY WERE TOLD THAT IT WAS OLD BLOOD AND THE PATIENT WAS GIVEN A BELT TO HOLD UP THE STOMACH AND GAUZE PADS FOR LEAKAGE AND TOLD TO FOLLOW UP WITH SURGEON. THE PATIENT FOLLOWED UP WITH DR AND THE PATIENT REPORTED THEY STILL HAD LEAKAGE WITH A FOUL ODOR THAT SMELLED LIKE FECES AND SWAB OR TEST FOR INFECTION WAS NOT PERFORMED. THE PATIENT GOT A SECOND OPINION A COUPLE OF DAYS LATER. THE DOCTOR PERFORMED A CULTURE TEST WITH SWAB AND PROVIDED ANOTHER BELT IN MEANTIME TO HOLD STOMACH IN PLACE AND GAUZE FOR THE LEAKAGE THAT WAS STILL COMING OUT. THE PATIENT WAS TOLD TO CHANGE THE GAUZE PADS AS NEEDED UNTIL THE RESULTS WERE BACK. A COUPLE OF DAYS PASSED AND THE PATIENT WAS TOLD THEY HAD A STAPH INFECTION. THE PATIENT REPORTED THEY WERE ON A COUPLE OF ANTIBIOTICS FOR ABOUT 4 WEEKS BECAUSE THEY HAD TO BE PUT ON DIFFERENT STRENGTH TO CLEAR TH

  Patient problems: Fluid Discharge; No Code Available; Not Applicable; Seroma; Unspecified Infection; Wound Dehiscence

  MAUDE report 7968264 ↗
• InjuryOct 1, 2018Adverse 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 GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7921745 ↗
• InjuryAug 31, 2018Adverse 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) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia; Not Applicable; Pain

  MAUDE report 7838343 ↗
• InjuryAug 23, 2018Adverse 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) 2011 AND MESH WAS IMPLANTED AND ON (B)(6) 2014 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 7809959 ↗
• InjuryJul 12, 2018Adverse 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) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7683897 ↗
• InjuryApr 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT HE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7474245 ↗
• InjuryApr 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN (B)(6) THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION AND MULTIPLE SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 7406510 ↗