ULTRAPRO UMS3 (UDI 10705031085947)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031085947), received between Apr 27, 2021 and May 29, 2025 — classified as 16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR A PARASTOMAL HERNIA FOLLOWING A CYSTECTOMY WITH AN ILEAL CONDUIT ON AN UNKNOWN DATE AND MESH WAS USED. THE PATIENT HAD A POTENTIAL ALLERGIC REACTION. THE WOUND BECAME INFECTED AND HAD TO BE TREATED AGAIN THIS YEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Impaired Healing; Post Operative Wound Infection

  MAUDE report 22109877 ↗
• InjuryNov 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2019 WITH MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND LOSS OF APPETITE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain

  MAUDE report 20756813 ↗
• InjuryNov 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2019 WITH MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 AND ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND LOSS OF APPETITE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain

  MAUDE report 20756809 ↗
• InjuryNov 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2019 WITH MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(4) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND LOSS OF APPETITE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Inflammation; Nausea; Pain

  MAUDE report 20756805 ↗
• InjuryNov 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 REPAIR OF RECURRENT INCISIONAL HERNIA ON (B)(6) 2019 WITH MESH. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT HERNIA REPAIR SURGERY ON (B)(6) 2020 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND LOSS OF APPETITE. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chills; Decreased Appetite; Diarrhea; Hernia; Inflammation; Nausea; Pain

  MAUDE report 20756804 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE.

  Patient problems: Insufficient Information

  MAUDE report 20638505 ↗
• InjuryNov 1, 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 REMOVAL SURGERY AND HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PALPABLE MASS, SCAR TISSUES WERE PRESENT, AND FLUIDS WERE EVACUATED. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2013 AND UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2014 DURING WHICH THE SURGEON NOTED ADHESIONS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 20584993 ↗
• InjuryOct 2, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT POSTERIOR PELVIC FLOOR REPAIR IN 2008 AND MESH WAS INSERTED. IN 2016, RECURRENCE OF PROLAPSE WAS NOTED, NORMAL FINDINGS AT TIME, PESSARY MANAGEMENT FROM THERE ON AND IN. IN 2022, IDENTIFIED TO HAVE SUSPICION OF MESH EXPOSURE ON POSTERIOR VAGINAL WALL, UNDERGONE INVESTIGATION AND CONFIRMS MESH EXPOSURE. ASYMPTOMATIC PATIENT, AND ONLY FOUND INCIDENTALLY GIVEN 6 MONTHLY PESSARY CHANGES. THE DEVICE REMAINS IMPLANTED IN PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erosion; Prolapse

  MAUDE report 20351741 ↗
• InjuryOct 1, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT ANTERIOR PELVIC FLOOR REPAIR IN 2004 AND MESH WAS IMPLANTED. THE PATIENT WAS REFERRED FOR POST MENOPAUSAL BLEEDING AND EXAMINATION IN 2022 BY SPECULUM. IDENTIFIED CERVICAL ABNORMALITY. FURTHER EVALUATION AFTER REFERRAL TO GYNAECOLOGY INDICATED SMALL MESH EXPOSURE ANTERIOR TO CERVIX. THE DEVICE REMAINS IMPLANTED IN PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20345459 ↗
• InjuryMar 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 A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DYSPAREUNIA, VAGINAL PAIN, ABDOMINAL PAIN, VAGINAL DISCHARGE, STRESS INCONTINENCE, URGENCY INCONTINENCE, URGENCY, THRUSH, VAGINAL INFECTION, CYSTOCELE AND DYSMENORRHEA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Incontinence; Micturition Urgency; Pain; Prolapse; Unspecified Infection

  MAUDE report 18863171 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2012 AND MESH WAS IMPLANTED. THE PATIENT WENT TO THE CLINIC WITH RECURRENT PROLAPSE AND A 3 X 1 CM MESH EXPOSURE WAS FOUND ON POSTERIOR VAGINAL WALL. NO OTHER SYMPTOMS WERE REPORTED BY THE PATIENT, INCIDENTAL FINDING OF MESH EXPOSURE. THE PATIENT WILL HAVE THE EXPOSED MESH REMOVED AT REPEAT REPAIR OF POSTERIOR VAGINAL WALL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erosion; Prolapse

  MAUDE report 17927585 ↗
• InjuryJul 3, 2023Adverse 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 REVISION SURGERY ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONSTIPATION, LOW BACK PAIN, URINE URGENCY, URGE INCONTINENCE, NOCTURIA, STRESS INCONTINENCE, VAGINAL DISCOMFORT, FREQUENCY, URINARY TRACT INFECTIONS, PELVIC PAIN, RECTAL BLEEDING, CYSTOCELE, VAGINAL BLEEDING, VOIDING DYSFUNCTION SYMPTOMS, VAGINAL DISCHARGE, ABDOMINAL BLOATING AND SWELLING, DYSURIA, LEG PAIN, BUTTOCK PAIN, ABDOMINAL PAIN, INFECTION, LOOSE STOOLS, FECAL INCONTINENCE, FIBROMYALGIA, GROIN PAIN, HIP PAIN, HEMORRHOIDS, ATROPHIC VAGINITIS AND BOWEL URGENCY THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2003 WHICH IS CAPTURED IN SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Distention; Abdominal Pain; Abnormal Vaginal Discharge; Autoimmune Disorder; Constipation; Diarrhea; Discomfort; Dysuria; Fecal Incontinence; Hemorrhage/Blood Loss/Bleeding; Incontinence; Inflammation; Micturition Urgency; Pain; Prolapse; Swelling/ Edema; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 17253201 ↗
• InjuryMay 24, 2023Adverse 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) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACK PAIN, VULVA ITCH, LEG PAIN, VAGINAL PAIN, GROIN PAIN, DYSPAREUNIA, ABDOMINAL PAIN, BOWEL URGENCY, FECAL LEAKING, URGENCY, HIP PAIN, URINARY INCONTINENCE, BOWEL INCONTINENCE, URINARY TRACT INFECTIONS, INCOMPLETE BLADDER EMPTYING, FREQUENCY, DYSURIA, THIGH PAIN, VAGINAL BLEEDING AND SUPRAPUBIC PRESSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Discomfort; Dysuria; Fecal Incontinence; Hemorrhage/Blood Loss/Bleeding; Incontinence; Itching Sensation; Micturition Urgency; Pain; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 17000162 ↗
• InjuryAug 2, 2022Adverse 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 HERNIA REPAIR OF LEFT INGUINAL HERNIA ON (B)(6) 2022 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT ON THE FOURTH DAY AFTER SURGERY, THE PATIENT DEVELOPED CONTINUOUS HIGH FEVER, REDNESS AROUND THE INCISION, AND THE INCREASE OF C-REACTIVE PROTEIN WAS OBVIOUS, BUT THE INFECTION INDICATORS SUCH AS HEMOGRAM AND PROCALCITONIN WERE NOT HIGH. IT WAS REPORTED THAT CONSIDERING THE REJECTION OF THE PRODUCT, THE ANTI INFECTION WAS STRENGTHENED, AND THE EFFECT OF ANTI-INFLAMMATORY TREATMENT WAS POOR, SO THE PRODUCT WAS TAKEN OUT IN THE EMERGENCY ON THE SECOND DAY AFTER SURGERY. IT WAS ALSO REPORTED THAT AFTER TAKING OUT THE PRODUCT, THE PATIENT'S TEMPERATURE GRADUALLY FELL TO NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fever; Inflammation; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 15148685 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THERE WAS POST-OP INFLAMMATION. IT WAS REPORTED THAT WHEN CHANGING THE DRESSING TWO DAYS AFTER SURGERY, THE INCISION WAS FOUND TO BE RED AND SWOLLEN. CONSIDERING THE REJECTION REACTION, IT IMPROVED AFTER STRENGTHENING WITH SYSTEMIC AND LOCAL TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction; Inflammation; Swelling/ Edema

  MAUDE report 13062427 ↗
• MalfunctionMay 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE HERNIA MESH HAD LARGE HOLES AND THERE IS HIGH POSSIBILITY OF THE HERNIA MESH SHEDDING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904007 ↗
• InjuryApr 27, 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 A GYNECOLOGICAL SURGICAL PROCEDURE ON 3/31/2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 11735651 ↗