ULTRAPRO UMS3 (UDI 10705031132504)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031132504), received between Aug 30, 2018 and Sep 10, 2019 — classified as 3 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 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 AN ABDOMINAL SACROCOLPOPEXY PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 8984433 ↗
• MalfunctionJul 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT DURING SURGERY, WHEN PLACING THE MESH, IT TORE WHILE BEING SUTURED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817460 ↗
• InjuryDec 19, 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 AN ANTERIOR PELVIC FLOOR REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED BLEEDING AND PAIN IN HER ABDOMEN, PELVIC AREA AND LOWER BACK. IT WAS REPORTED THAT SHE EXPERIENCED INCONTINENCE AND URINARY TRACT INFECTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Incontinence; Urinary Tract Infection

  MAUDE report 8177696 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2018 AND THE MESH WAS IMPLANTED. ON (B)(6) 2018, BILATERAL GROIN INCISION ABSCESS WAS OBVIOUS, THE INCISION OPENED AND A LARGE AMOUNT OF PURULENT FLUID CAME OUT. THE PATIENT UNDERWENT A SECOND SURGERY ON (B)(6) 2018 TO REMOVE THE MESH AND MEDICINE WAS USED ON INCISION. IT WAS REPORTED THAT NOW THE PATIENT STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Not Applicable; Purulent Discharge; Unspecified Infection

  MAUDE report 7834225 ↗