ULTRAPRO UML1 (UDI 10705031132399)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031132399), received between Aug 3, 2018 and Feb 18, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 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 HERNIA REPAIR ON(B)(6)2020 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON (B)(6)2013 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON (B)(6)2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, NAUSEA, VOMITING, TENDERNESS, AND ADHESIONS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION CAN BE ADDED

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nausea; Pain; Vomiting

  MAUDE report 21395562 ↗
• InjuryJan 13, 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 REMOVAL SURGERY WITH NEW IMPLANT ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. IT WAS REPORTED THAT THE PATIENT HAD HERNIA REPAIR ON 6/9/2015 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 21135321 ↗
• InjuryNov 13, 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) 2015 MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES AND CAPTURED IN A SEPARATE FILE.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain; Weight Changes

  MAUDE report 20671383 ↗
• InjuryAug 29, 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 REPAIR ON (B)(6) 2011 AND MESH WAS IMPLANTED. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2006 WHICH IS CAPTURED IN SEPARATE FILE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR ON (B)(6) 2010 AND (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIONS, BOWEL PERFORATION AND PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain; Perforation

  MAUDE report 20097219 ↗
• MalfunctionOct 29, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE MESH WAS DELIVERED ON (B)(6) 2021. IT WAS REPORTED THAT UPON DELIVERY BOTH THE CARTON AND THE INNER PACKAGING WERE TORN. IT WAS REPORTED THAT THE DEVICE WAS NOT USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720593 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STOMACHACHE. IT WAS ALSO REPORTED THAT ON (B)(6) 2021 THE PATIENT HAD AN X-RAY TAKEN AND IT WAS FOUND THAT THE MESH ADHERED TO THE INTESTINAL TRACT. THE MESH WAS LEFT IN THE INTRAPERITONEAL CAVITY AND A RE-OPERATION WAS SCHEDULED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 12243120 ↗
• InjuryAug 28, 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 EXPERIENCED CYSTOCELE, AND PROLAPSE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7825004 ↗
• InjuryAug 10, 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) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS AND INTRAABDOMINAL/INTRAPELVIC ADHESION. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Not Applicable; Urinary Tract Infection

  MAUDE report 7773543 ↗
• InjuryAug 3, 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 7749250 ↗