ULTRAPRO UMR3 (UDI 10705031085923)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031085923), received between Nov 28, 2019 and Dec 11, 2024 — classified as 7 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse 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) 2011 AND MESH AND MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20902610 ↗
• InjuryNov 26, 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)2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6)2013 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON (B)(6)2001. OTHER PROCEDURES WERE CAPTURED IN A SEPARATE FILE. THE PATIENT EXPERIENCED UNDISCLOSED INJURIES.

  Patient problems: Insufficient Information

  MAUDE report 20785610 ↗
• InjuryNov 19, 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL OF MESH ON (B)(6) 2013. THE PATIENT EXPERIENCED PAIN, INFECTION, ADHESIONS, NAUSEA, SEROMA, AND HEMATOMA. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hematoma; Nausea; Pain; Seroma; Unspecified Infection

  MAUDE report 20720253 ↗
• InjuryJun 5, 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) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL AND REVISION SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FATIGUE, POLYDIPSIA, CHRONIC INFECTION, CHRONIC FISTULA AND CHRONIC PAIN, FLUID ACCUMULATION IN THE ABDOMINAL WALL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fatigue; Fistula; Pain; Polydipsia; Unspecified Infection

  MAUDE report 14599707 ↗
• InjuryJan 20, 2020Adverse 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 UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2017 DURING WHICH THE SURGEON NOTED THE ADHESED MESH HAD CONTRACTED INTO A WADDED MASS, REVEALING A MIDLINE DEFECT OF ABOUT 3 CM WITH OMENTUM PROTRUDING. THE SURGEON REMOVED THE WADDED MESH AND SURROUNDING FIBROTIC TISSUE AND SENT TO PATHOLOGY. THE PATHOLOGY REPORT NOTED CHRONIC INFLAMMATION AND REACTIVE FIBROSIS SECONDARY TO MESH. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Adhesion(s); Fibrosis; Inflammation

  MAUDE report 9607976 ↗
• InjuryDec 27, 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 REPAIR OF LEFT INGUINAL HERNIA ON (B)(6) 2012 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 9526612 ↗
• InjuryNov 28, 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 A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED DUE TO POP. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 9390524 ↗