ULTRAPRO UMM3 (UDI 10705031132481)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031132481), received between Mar 7, 2018 and Jul 31, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 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 REVISION SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2009 AND TWO (2) MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESION AND PAIN. OTHER PROCEDURE WAS CAPTURED ON A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 22674982 ↗
• InjuryApr 8, 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 REVISION SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA RECURRENCE, TINGLING SENSATION IN THE GROIN, ADHESIONS IN THE PROPERITONEAL SPACE, DENSE SIGNIFICANT SCAR TISSUE, MESHOMA AT THE INTERNAL RING - MESH CONTRACTION, AND MESH SHRINKAGE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Scar Tissue

  MAUDE report 21802469 ↗
• InjuryMar 8, 2019Adverse 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 RIGHT INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2007 DURING WHICH THE SURGEON NOTED THE PREVIOUSLY PLACED MESH HAD FOLDED INTO THE INTERNAL RING AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HIS RIGHT GROIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 8404327 ↗
• InjuryFeb 15, 2019Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS 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: Adhesion(s); Erosion; Fistula; Not Applicable; Pain

  MAUDE report 8345607 ↗
• InjuryDec 23, 2018Adverse 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 HERNIA REPAIR SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED HERNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia; Not Applicable

  MAUDE report 8193264 ↗
• InjuryDec 12, 2018Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2004, AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007, AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2014, AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED BLOOD IN URINE, STRESS INCONTINENCE, BLEEDING FROM VAGINAL AREA, RECTOCELE, PROLAPSE VAGINAL WALLS, AND FEMALE PELVIC PAIN. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blood Loss; Hematuria; Incontinence

  MAUDE report 8154171 ↗
• InjuryDec 12, 2018Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED BLOOD IN URINE, STRESS INCONTINENCE, BLEEDING FROM VAGINAL AREA, RECTOCELE, PROLAPSE VAGINAL WALLS, AND FEMALE PELVIC PAIN. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blood Loss; Hematuria; Incontinence

  MAUDE report 8154168 ↗
• InjuryOct 29, 2018Adverse 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 ON (B)(6) 2014 AND MESH WERE IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Micturition Urgency; Not Applicable; Pain; Urinary Frequency / Polyuria; Urinary Retention

  MAUDE report 8014325 ↗
• InjuryOct 16, 2018Migration; Migration

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND MESH WAS 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; Micturition Urgency; Not Applicable; Pain; Urinary Frequency / Polyuria

  MAUDE report 7968348 ↗
• InjuryJul 12, 2018Adverse 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 HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7683934 ↗
• InjuryJun 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7627824 ↗
• MalfunctionMay 1, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2018 AND MESH WAS USED. THE STERILE PACKAGE WAS FOUND BROKEN BEFORE USE ON THE PATIENT. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7477475 ↗
• InjuryMar 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE IN (B)(6) 2014 AND MESH WAS IMPLANTED. THE PATIENT REPORTED THAT THEY EXPERIENCED SHARP PAIN IN THE GROIN AREA AND WENT TO THE EMERGENCY ROOM IN (B)(6) 2017. THE MESH WAS REMOVED FROM SEVERAL PLACES INSIDE OF THE PATIENT IN (B)(6) 2018. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Not Applicable; Pain

  MAUDE report 7320813 ↗