ULTRAPRO ADVANCED UPA31015Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705031236998), received between Dec 10, 2018 and Sep 24, 2026 — classified as 3 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (23 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Device Contaminated During Manufacture or Shipping

  It was reported that a patient underwent a Laparoscopic tension-free repair of inguinal hernia procedure on (b)(6) 2026, and suture was used. The nurse took out a patch and opened the aluminum foil bag to find a white linear foreign object on the patch. To be safe, a new patch was used instead. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882226 ↗
• MalfunctionDec 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON AN (B)(6) 2025 AND MESH WAS USED. FLOCCULENT ON THE MESH. WHILE CUTTING A PATCH DURING THE OPERATION, THE CHIEF SURGEON DISCOVERED AN UNKNOWN "FLOCCULENT" OBJECT ON THE SURFACE OF THE PATCH. FOR THE SAFETY OF THE PATIENT, THE CUT PATCH WAS NOT IMPLANTED INTO THE PATIENT'S BODY. THE DOCTOR REOPENED A PIECE AND FOUND NO SIMILAR SUBSTANCE, THEN COMPLETED THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810514 ↗
• 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 20344169 ↗
• 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 20344161 ↗
• 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 20273033 ↗
• 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 20273010 ↗
• 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 LARGER HOLE IN THE FOIL PACK OF THE MESH. 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 20272937 ↗
• 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 20272686 ↗
• 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 THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272253 ↗
• MalfunctionJul 24, 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. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. WHEN HOLE WAS DETECTED, THEY DID NOT USE THE PRODUCT. THEY OPENED A NEW MESH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822456 ↗
• 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 19750972 ↗
• MalfunctionJul 8, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE 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. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691317 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LICHETENSTEIN HERNIA REPAIR ON AN UNKNOWN DATE IN 2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE MESH WAS TAKEN OUT ON (B)(6) AND MYCOBACTERIUM WAS FOUND IN VITRO CULTURE. IT WAS CONSIDERED THAT THE PATIENT'S INFECTION WAS RELATED TO THE MESH PRODUCT. THE PATIENT UNDERWENT LICHTENSTEIN HERNIA REPAIR 20 DAYS BEFORE (B)(6), AND THE DATE OF THE FIRST OPERATION IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Local Reaction; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12926561 ↗
• MalfunctionNov 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON AN UNKNOWN DATE IN 2021 AND THE MESH WAS USED. PRIOR TO SURGERY, IT WAS FOUND THAT THE PRIMARY PACKAGING WAS DEFECTIVE. IT WAS REPORTED THAT THE FOIL PACKAGING OF THE MESH SHOWED A SERIES OF PUNCTIFORM INDENTATIONS, BUT IT WAS UNCLEAR WHETHER THE FOIL ACTUALLY PERFORATED. A LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740915 ↗
• MalfunctionMay 23, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND THE MESH WAS USED. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE AND CONDUCTING A VISUAL INSPECTION FOR DAMAGE, THERE WERE HOLES FOUND IN THE ALUMINUM PACKAGING. THE SURGERY WAS COMPLETED WITH A NEW DEVICE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868787 ↗
• MalfunctionMay 23, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND THE MESH WAS USED. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE AND CONDUCTING A VISUAL INSPECTION FOR DAMAGE, THERE WERE HOLES FOUND IN THE ALUMINUM PACKAGING. THE SURGERY WAS COMPLETED WITH A NEW DEVICE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868786 ↗
• MalfunctionMay 23, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND THE MESH WAS USED. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE AND CONDUCTING A VISUAL INSPECTION FOR DAMAGE, THERE WERE HOLES FOUND IN THE ALUMINUM PACKAGING. THE SURGERY COMPLETED WITH NEW DEVICE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868678 ↗
• MalfunctionMay 23, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND THE MESH WAS USED. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE AND CONDUCTING A VISUAL INSPECTION FOR DAMAGE, THERE WERE HOLES FOUND IN THE ALUMINUM PACKAGING. THE SURGERY COMPLETED WITH NEW DEVICE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868677 ↗
• MalfunctionMay 23, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND THE MESH WAS USED. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE AND CONDUCTING A VISUAL INSPECTION FOR DAMAGE, THERE WERE HOLES FOUND IN THE ALUMINUM PACKAGING. THE SURGERY COMPLETED WITH NEW DEVICE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868676 ↗
• MalfunctionMay 23, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND THE MESH WAS USED. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE AND CONDUCTING A VISUAL INSPECTION FOR DAMAGE, THERE WERE HOLES FOUND IN THE ALUMINUM PACKAGING. THE SURGERY COMPLETED WITH NEW DEVICE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868675 ↗
• MalfunctionMar 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON AN UNKNOWN DATE IN (B)(6) 2021 AND THE MESH WAS USED. PRIOR TO SURGERY THERE WERE HOLES FOUND IN FOIL OF DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572557 ↗
• MalfunctionMar 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON AN UNKNOWN DATE IN 2021 AND THE MESH WAS USED. PRIOR TO SURGERY THERE WERE HOLES FOUND IN FOIL OF DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572556 ↗
• MalfunctionMar 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON AN UNKNOWN DATE IN 2021 AND THE MESH WAS USED. PRIOR TO SURGERY THERE WERE HOLES FOUND IN FOIL OF DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572555 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA SURGERY USING THE TAPP METHOD ON (B)(6) 2020, AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2020, AND IT APPEARS THAT IN ONE GROIN OF HIS, THERE IS AN ABSCESS RESULTING FROM AN INFECTION THAT CAUSED IN THE OPERATING. AN EXAMINATION PERFORMED AT THE HOSPITAL REVEALED THAT THERE WAS A PRESENCE OF THE BACTERIUM MYCOBACTERIUM GOODII IN THE AREA OF THE ABSCESS. ACCORDING TO THE DOCTOR, THIS BACTERIUM IS NOT USUALLY PRESENT IN THE BODY, AND ITS PRESENCE RAISES SUSPICION THAT IT CAN BE ORIGINATED IN THE EQUIPMENT USED DURING THE OPERATION. IT WAS REPORTED THAT THE DOCTOR WHO RECEIVED THE PATIENT AFTER HIS RETURN TO THE HOSPITAL, SAID THAT IT IS NOT KNOWN ABOUT A DIRECT LINK BETWEEN THE DEVELOPMENT OF THE ABSCESS / THE PRESENCE OF THE BACTERIUM, AND BETWEEN THE MESH THAT WAS USED TO REPAIR THE HERNIA. IN HIS VIEW, AT THIS STAGE THERE IS A POSSIBILITY THAT ANY OTHER TOOL THAT WAS USED IN THE SURGERY MIGHT HAVE CAUSED THE INFECTION. IT WAS REPORTED THAT AFTER THE PATIENT RETURNED TO THE HOSPITAL, AN ABSCESS DRAINAGE PROCEDURE WAS PERFORMED, AND TESTS WERE TAKEN. IT WAS ALSO

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 10906703 ↗
• MalfunctionNov 13, 2020Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE MESH WAS USED PRIOR TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE ULTRAPRO MESH SHOWED PERFORATION OF INNER PACKAGING. IT WAS REPORTED THAT THE STERILITY MIGHT BE COMPROMISED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10840639 ↗