ULTRAPRO UMM3 (UDI 10705031085886)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031085886), received between Jan 27, 2020 and Mar 14, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 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 REPAIR OF INCARCERATED RECURRENT INCISIONAL HERNIA ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL INCARCERATED EPIGASTRIC UPPER ABDOMINAL VENTRAL HERNIA. IT WAS PREVIOUSLY REPORTED THAT PATIENT HAD UNDERWENT HERNIA REPAIR ON (B)(6) 2016 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia; Pain

  MAUDE report 21603650 ↗
• InjuryFeb 5, 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 RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2007 AND TWO MESHES WERE IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21318447 ↗
• InjuryJan 19, 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 REMOVAL SURGERY ON (B)(6) 2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED DUE TO EPIGASTRIC HERNIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES.

  Patient problems: Insufficient Information

  MAUDE report 21188212 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENSION FREE REPAIR OF INGUINAL HERNIA PROCEDURE (B)(6) 2024 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED POST-OP INFLAMMATION AND WOUND SECRETION. THE PATIENT WAS PLACED WITH PATCH DURING THE SURGERY. AFTER THE SURGERY, THE PATIENT EXPERIENCED INCISION PAIN, ACCOMPANIED BY REDNESS AND A SMALL AMOUNT OF EXUDATE, SUGGESTING A POSSIBLE REACTION TO THE PATCH. ADMINISTER MEDICATION THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Inflammation; Pain; Skin Inflammation/ Irritation

  MAUDE report 20860547 ↗
• InjuryAug 22, 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 SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED ADHESIONS, OBSTRUCTIONS, SCAR AND SWELLING. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2011 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Obstruction/Occlusion; Scar Tissue; Swelling/ Edema

  MAUDE report 20029359 ↗
• InjuryMar 12, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MESH EROSION, PAIN AND BOWEL ISSUES. NO FURTHER INFORMATION IS AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

  Patient problems: Erosion; Pain

  MAUDE report 18887037 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND MESH WAS IMPLANTED. ON THE 11TH DAY AFTER SURGERY, THERE WAS FLUID ACCUMULATION AT THE SURGICAL INCISION, AND SECRETION CULTURE WAS PERFORMED TO CULTIVATE STAPHYLOCOCCUS EPIDERMIDIS. CLINICAL PHARMACY CONSULTATION WAS REQUESTED, AND LOCAL ANTIBIOTICS WERE USED FOR DRESSING CHANGE. AFTER ACTIVE DRESSING CHANGE, THERE WAS NO SIGNIFICANT IMPROVEMENT IN THE LEAKAGE AT THE SURGICAL INCISION. ON THE 19TH DAY AFTER SURGERY, IT WAS CONSIDERED THAT THE INFECTION WAS CAUSED BY THE PLACEMENT OF THE PATCH OR DUE TO LEAKAGE AND IMPROPER CARE. PART OF THE EXPOSED PATCH WAS REMOVED, AND FURTHER DRESSING CHANGE TREATMENT WAS STRENGTHENED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 18759848 ↗
• MalfunctionOct 21, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON 09/30/2022 THE MESH WAS USED. IT WAS REPORTED THAT THE PRODUCT WAS RECEIVED WITHOUT SOURCE LABEL. IT WAS REPORTED THAT THIS ISSUE WAS IDENTIFIED AT THE TIME OF PERFORMING REPACK RELABEL ACTIVITIES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655410 ↗
• InjuryJun 20, 2022Adverse 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 SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14749241 ↗
• InjuryJan 11, 2022Adverse 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 VENTRAL HERNIA REPAIR SURGERY ON AN UNK DATE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2002, (B)(6) 2003, (B)(6) 2009, (B)(6) 2014 AND UNK DATE AND MESH X5 WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH ADHESION, INFECTION, PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13216964 ↗
• InjuryJan 11, 2022Adverse 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 VENTRAL HERNIA REPAIR SURGERY ON AN UNK DATE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2002, (B)(6) 2003, (B)(6) 2009, (B)(6) 2014 AND UNK DATE AND MESH X5 WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH ADHESION, INFECTION, PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13216949 ↗
• InjuryJan 11, 2022Adverse 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 VENTRAL HERNIA REPAIR SURGERY ON AN UNK DATE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2002, (B)(6) 2003, (B)(6) 2009, (B)(6) 2014 AND UNK DATE AND MESH X5 WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH ADHESION, INFECTION, PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13216926 ↗
• InjuryJan 11, 2022Adverse 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 VENTRAL HERNIA REPAIR SURGERY ON AN UNK DATE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2002, (B)(6) 2003, (B)(6) 2009, (B)(6) 2014 AND UNK DATE AND MESH X5 WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH ADHESION, INFECTION, PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13216788 ↗
• InjuryJan 11, 2022Adverse 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 VENTRAL HERNIA REPAIR SURGERY ON AN UNK DATE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR SURGERY ON (B)(6) 2002, (B)(6) 2003, (B)(6) 2009, (B)(6) 2014 AND UNK DATE AND MESH X5 WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MESH ADHESION, INFECTION, PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. OTHER PROCEDURES ARE CAPTURED UNDER SEPARATE FILES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13216583 ↗
• InjuryDec 14, 2021Adverse 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 SURGERY ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LYSIS OF ADHESION, INFECTED ABDOMINAL WALL, ABSCESS FORMATION AND RECURRENCE HERNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED WHICH IS CAPTURED IN A SEPARATE FILE.

  Patient problems: Abscess; Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 12992966 ↗
• InjuryJan 29, 2021Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND TWO MESH PRODUCTS WERE IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 11250194 ↗
• InjuryOct 7, 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 A GYNECOLOGICAL SURGICAL PROCEDURE IN (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 10643310 ↗
• InjuryJan 27, 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 HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA,FISTULA, INFECTION AND ADHESION. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED. OTHER PROCEDURE IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 9632802 ↗