ULTRAPRO UPPM6Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031132597), received between Oct 25, 2021 and Sep 16, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 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 RECURRENT INGUINAL HERNIA REPAIR SURGERY ON (B)(6)2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, RIGHT GROIN PAIN AND BULGE. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD RECURRENT HERNIA REPAIR ON (B)(6)2012, (B)(6)2013, (B)(6)2013, AND ON (B)(6)2016. OTHER PROCEDURES WERE CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20232887 ↗
• InjuryAug 8, 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 RECURRENT LEFT INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19944220 ↗
• InjuryOct 29, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR ON AN UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RECURRING HERNIA FIVE YEARS POST OP. IT WAS REPORTED THAT THE ORIGINAL MESH WAS COMPLETELY GONE, BUT THE MESH FIXATION SUTURE WAS VISIBLE. IT WAS ALSO REPORTED THAT THE MESH DISAPPEARED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 12724035 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE A YEAR AGO AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN. IT WAS ALSO REPORTED THAT ON (B)(6) 2021 THE PATIENT'S DOCTOR FOUND A BULGE IN THE PATIENT'S ABDOMEN AND RECOMMENDED REMOVAL OF THE MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12694139 ↗