ULTRAPRO ADVANCED UPA1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031236950), received between Mar 3, 2022 and Mar 10, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. DURING THE OPENING AND JUST BEFORE AUTHORIZING THE SURGEON TO USE THE IMPLANT, THE NURSE DISCOVERED BY INSPECTING THE ALUMINIZED PACKAGING THAT THERE WAS A SMALL HOLE IN IT, THE EDGES OF WHICH MEANT THAT THE PIERCING HAD BEEN DONE FROM THE INSIDE TO THE OUTSIDE. THE IMPLANT HAS NOT BEEN USED. NO PATIENT CONSEQUENCE. ANOTHER DEVICE WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566912 ↗
• MalfunctionNov 13, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND MESH WAS USED. UPON OPENING, IT WAS FOUND THAT THE PACKAGING HAS A HOLE. THE NET WAS NOT USED. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120820 ↗
• InjuryApr 25, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE (YEARS AGO) AND MESH WAS IMPLANTED. THE PATIENT REPORTED THE MESH IS NO LONGER AT THE RIGHT PLACE, IT DISAPPEARED AND IS NOW SOMEWHERE IN THE PATIENT'S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erosion; Failure of Implant; Inflammation

  MAUDE report 16809952 ↗
• MalfunctionMar 3, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND THE MESH WAS USED. IT WAS REPORTED THAT A HOLE WAS FOUND IN SILVER BLISTER PACKAGING OF MESH. IT WAS ALSO REPORTED THAT THE MESH WAS NOT USED IN PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664772 ↗