ULTRAPRO ADVANCED UPA31515Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031237001), received between Nov 26, 2020 and Oct 1, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 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 18, 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.

• MalfunctionOct 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AROUND (B)(6) 2024 AND MESH WAS USED. THE NURSE IN THE OR TAKES THE MESH OUT OF THE ENVELOPE IT IS IN. (THEY ARE PACKED 3 PIECES IN THE SAME ENVELOPE). OPENS THE NEXT PACKAGE THAT IS MADE OF SOME KIND OF FOIL. OR NURSE TAKES THE MESH OUT OF THE PACKAGE. USK THEN OPENS UP THE ENTIRE PACKAGE AND EYES IT AGAINST A LIGHT SOURCE IN THE CEILING, THEREBY DETECTING TINY, MICROSCOPIC HOLES. THE NET IS DISCARDED BECAUSE STERILITY CANNOT BE GUARANTEED. THERE WAS ONE PRETTY "BIG" HOLE SO IT CAN BE SEEN WELL OTHERWISE THEY CAN BE SO SMALL THAT IT IS DIFFICULT TO DETECT AND IF YOU DO NOT USE A LIGHT SOURCE WHEN YOU LOOK AT THE PACKAGING, THE HOLES PROBABLY GO UNNOTICED. NEW MESH IS OPENED AND UNDERGO THE SAME INSPECTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344128 ↗
• MalfunctionSep 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL HOLES IN THE FOIL PACK OF THE MESH WHICH LOOKS LIKE PUNCH HOLES. IT IS MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THERE WAS NO DELAY DUE TO THE REPORTED EVENT AND NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272793 ↗
• MalfunctionSep 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL HOLES IN THE FOIL PACK OF THE MESH WHICH LOOKS LIKE PUNCH HOLES. IT IS MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THERE WAS NO DELAY DUE TO THE REPORTED EVENT AND NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272786 ↗
• MalfunctionJul 23, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL HOLES IN THE FOIL PACK OF THE MESH. MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THE MESH WAS NOT USED ON THE PATIENT. A NEW MESH IS OPENED AND THAT FOIL PACK IS CHECKED FOR HOLES BEFORE USE IN PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812175 ↗
• MalfunctionJul 23, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL HOLES IN THE FOIL PACK OF THE MESH. MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. NO HOLES WERE DETECTED ON THE OUTER PAPER BOX. THE MESH WAS NOT USED ON THE PATIENT. A NEW MESH IS OPENED AND THAT FOIL PACK IS CHECKED FOR HOLES BEFORE USE IN PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811924 ↗
• MalfunctionJul 16, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND MESH WAS USED. THE HEALTHCARE PROFESSIONAL DISCOVERED SMALL SMALL HOLES IN THE FOIL PACK OF THE MESH. MICROSCOPICAL, BUT DETECTABLE IN A DARK ROOM WITH LIGHTS THROUGH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. WHEN HOLE WAS DETECTED, THEY DID NOT USE THE PRODUCT. THEY OPENED A NEW MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750966 ↗
• InjuryNov 26, 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 REMOVAL SURGERY AN RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2018 AND THE MESH WAS IMPLANTED DURING WHICH THE SURGEON NOTED THE PREVIOUS MESH WAS PROTRUDING AND WAS EXCITED FROM THE EDGES OF THE FASCIA. 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 PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2008 AND PROCEED WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Diarrhea; Nausea

  MAUDE report 10912566 ↗