GYNECARE TVT 810041BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031062290), received between Jun 12, 2024 and May 14, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6) RECEIVED AN E-MAIL FROM THE ETHICON RISK MANAGER TEAM STATING THE FOLLOWING: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 AND TVT-O WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, HIP PAIN, BACK PAIN, ABDOMEN PAIN, FREQUENT URINARY TRACT INFECTIONS, URINARY INCONTINENCE, AND BOWEL INCONTINENCE, VAGINAL PROLAPSE AND PAIN DURING INTERCOURSE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Erosion; Pelvic Pain; Prolapse; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 25173907 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  A 55-YEAR-OLD FEMALE PATIENT BEING TREATED FOR MULTIPLE SCLEROSIS COMPLICATED BY NEUROGENIC BLADDER, PRESENTING WITH MIXED URINARY INCONTINENCE - PREDOMINANTLY STRESS INCONTINENCE[?]ASSOCIATED WITH URGE INCONTINENCE. IN THIS CONTEXT, A TVT-TYPE SUBURETHRAL SLING WAS IMPLANTED IN APRIL 2022. THE COURSE OF THE CONDITION WAS MARKED IN 2025 BY THE DEVELOPMENT OF SLING EROSION AT THE LEVEL OF THE ANTERIOR VAGINAL WALL. SURGICAL MANAGEMENT WAS PERFORMED ON (B)(6) 2025, CONSISTING OF PARTIAL REMOVAL OF THE SLING VIA THE VAGINAL ROUTE WITH EXCISION OF 12 MM OF SUBURETHRAL MATERIAL. SUBSEQUENTLY, ON (B)(6) 2026, A RECURRENCE WAS OBSERVED WITH BILATERAL EROSION OF THE SLING ON EITHER SIDE OF THE URETHRA, ASSOCIATED WITH PROTRUSION OF A FEW MILLIMETERS OF SLING INTO THE VAGINA ON EACH SIDE. IN LIGHT OF THIS PERSISTENT COMPLICATION, THE DECISION WAS MADE TO PROCEED WITH COMPLETE REMOVAL OF THE DEVICE. A ROBOT-ASSISTED LAPAROSCOPIC PROCEDURE TO REMOVE BOTH ARMS OF THE SLING WAS PERFORMED ON (B)(6) 2026. THE DEVICE IS AVAILABLE AT THE HOSPITAL PITIÉ-SALPETRIÈRE AND IN WAITING TO BE RETURNED.

  Patient problems: Erosion

  MAUDE report 25166880 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED: THE IMPLANT WAS PERFORMED ON (B)(6) 2023, AND IMMEDIATELY UPON AWAKENING FROM THE PROCEDURE I EXPERIENCED SEVERE PAIN IN THE RIGHT GROIN, ALONG WITH DIFFICULTY STANDING AND EMPTYING MY BLADDER. THIS PAIN HAS NEVER RESOLVED AND HAS PROGRESSIVELY SPREAD INTO MY HIP, DOWN MY THIGH, AND BELOW THE KNEE. DESPITE NUMEROUS TREATMENTS ATTEMPTED FOR PAIN RELIEF, NONE HAVE BEEN EFFECTIVE, AND I AM CURRENTLY ON MORPHINE. MY FUNCTIONAL CAPACITY IS SEVERELY LIMITED: I CAN STAND FOR NO MORE THAN 15 MINUTES AND WALK FOR ONLY 5 MINUTES, WHILE SITTING OR LYING DOWN IS EXTREMELY PAINFUL AND CAUSES SEVERE INSOMNIA. AT NIGHT, I AM FORCED TO CHANGE POSITION EVERY TWO HOURS BECAUSE I CANNOT TOLERATE MAINTAINING ANY POSTURE. FOR OUTDOOR MOBILITY, I MUST USE A MANUAL WHEELCHAIR. I ALSO SUFFER FROM UNBEARABLE PAIN AND SIGNIFICANT DIFFICULTY WITH URINATION. SUBSEQUENT MEDICAL EXAMINATIONS REVEALED A LARGE LONGITUDINAL EROSION OF THE URETER, AND A BLUE STRIP IS VISIBLE BY TRANSPARENCY THROUGH THE VAGINAL WALL. SINCE THIS INTERVENTION, WHICH WAS PRESENTED AS SAFE AND QUICK, MY QUALITY OF LIFE HAS BEEN DEVASTATINGLY ALTERED, AND MY LIFE AS A WIFE AND MOTHER OF FOUR CHILDREN HAS BEEN PROFOUND

  Patient problems: Erosion; Pain; Urinary Retention

  MAUDE report 25115503 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MHRA HEALTH AUTHORITY REPORTED THE FOLLOWING: THERE HAS BEEN ONGOING DYSPAREUNIA (PAINFUL INTERCOURSE) AND VAGINAL BLEEDING FOR THE PAST TWO YEARS. A 0.5 CM AREA OF MESH EXTRUSION HAS BEEN OBSERVED AT THE MID-URETHRA, LOCATED JUST TO THE LEFT OF THE MIDLINE. THIS CASE SHOULD BE DISCUSSED AT THE MDT (MULTIDISCIPLINARY TEAM MEETING), AND A REFERRAL TO A SPECIALIZED MESH CENTER IS RECOMMENDED. THE AVAILABILITY OF THE DEVICE IS CURRENTLY UNKNOWN. MHRA REFERENCE NUMBER: (B)(4).

  Patient problems: Dyspareunia; Erosion; Genital Bleeding; Pain

  MAUDE report 23482707 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FOLLOWED FOR MULTIPLE SCLEROSIS, CURRENTLY ON OCREVUS. THE PATIENT IS AUTONOMOUS IN WALKING AND HAS A KNOWN NEURO-BLADDER. SHE PRESENTED MIXED URINARY INCONTINENCE, PREDOMINANTLY EFFORT, WITH ALSO SOME IMPERIOSITIES IN THE CONTEXT OF HER NEUROVESSIE. A TVT-TYPE SUBURETHRAL SLING WAS PLACED ON DATE#1, WITH A FAVORABLE OUTCOME: SPONTANEOUS URINATION, WITHOUT DIFFICULTY OR RECURRENCE OF INCONTINENCE. FOR A FEW MONTHS, THE PATIENT HAS REPORTED THE REAPPEARANCE OF A MORE MARKED EMERGENCY, ASSOCIATED WITH MALODOROUS VAGINAL DISCHARGE. ENDOSCOPIC EXPLORATION WAS THEREFORE PROGRAMMED TO ELIMINATE EROSION OF THE STRIP.

  Patient problems: Abnormal Vaginal Discharge; Erosion; Urinary Frequency / Polyuria

  MAUDE report 23472387 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A TENSION-FREE VAGINAL TAPE (TVT) PROCEDURE IN (B)(6) 2017. SINCE (B)(6) 2019, SHE HAS BEEN EXPERIENCING PELVIC PAIN, LOW BACK PAIN, AND RECURRENT CYSTITIS, AVERAGING ONE EPISODE PER MONTH. SHE HAS BEEN MANAGING HER SYMPTOMS WITH SELF-MEDICATION USING MONURIL® OR SELEXID® ALTERNATELY, WITHOUT PRIOR URINE CULTURE (ECBU). THE PATIENT REPORTS SYMPTOMS OF POLLAKIURIA AND URINARY INCONTINENCE, WHICH HAVE NECESSITATED THE USE OF DAILY PROTECTIVE WEAR. NOTABLY, SHE EXPERIENCES THE "KEY-IN-THE-DOOR" SYNDROME BUT DOES NOT HAVE STRESS INCONTINENCE. A GYNECOLOGICAL EXAMINATION REVEALS GOOD VULVAR HEALTH, BUT THERE IS PAIN UPON PALPATION OF BOTH THE ANTERIOR AND POSTERIOR STRIPS OF THE PROMONTOFIXATION, MORE PRONOUNCED IN THE POSTERIOR STRIP, WITHOUT ANY SIGNS OF VAGINAL EROSION. SHE IS ALSO RECEIVING GYNECOLOGICAL CARE DUE TO A RECURRENCE OF LESIONS RELATED TO PAPILLOMAVIRUS, AND A CONTROL SMEAR IS PENDING. CYSTOSCOPY REVEALED HEALTHY, NON-INFLAMMATORY BLADDER MUCOSA WITH NO EROSIONS ON THE ANTERIOR STRIP OR THE TVT. THERE WERE NO STONES OR POLYPS, AND BOTH THE URETERS AND URETHRA APPEARED HEALTHY, THOUGH THE URETHRA EXHIBITED SLIGHT INFLAMMATION. THE PATIENT EXPERIENCED

  Patient problems: Interstitial Cystitis; Pain; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 23399054 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT, WHO HAD A HISTORY OF URINARY INCONTINENCE DATING BACK TO 2016, EXPERIENCED A RECURRENCE OF STRESS URINARY INCONTINENCE. TO ADDRESS THIS, SHE RECEIVED A TENSION-FREE VAGINAL TAPE (TVT) STRIP (REF. 810041BL; LOT 3822871; JOHNSON & JOHNSON). UNFORTUNATELY, AFTER AN EARLY FAILURE, SHE EXPERIENCED A RETURN OF INCONTINENCE FOLLOWING A COUGHING EPISODE RELATED TO PERTUSSIS. AS A RESULT, A SECOND TVT STRIP WAS PLACED, AND A RECTOCELE REPAIR WAS PERFORMED THROUGH THE VAGINAL ROUTE IN (B)(6) 2017.

  Patient problems: Interstitial Cystitis; Pain; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 23398868 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE WCQ RECEIVED AN EMAIL FROM THE ETHICON RISK MANAGER TEAM REPORTING THE FOLLOWING: THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2005, DURING WHICH A TVT (TENSION-FREE VAGINAL TAPE) WAS IMPLANTED. THE PATIENT SUBSEQUENTLY HAD REVISION SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, AN ENDOMETRIAL POLYP, IRREGULAR BLEEDING, A CYSTOCELE, AND STRESS URINARY INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Prolapse; Urinary Incontinence

  MAUDE report 23369245 ↗
• InjuryOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY MANAGED ON DATE #1 FOR A VAGINAL HYSTERECTOMY, WHICH INCLUDED THE PLACEMENT OF A TVT STRIP AND A RICHTER'S PROCEDURE FOR STAGE 2 PROLAPSE, ACCOMPANIED BY STRESS URINARY INCONTINENCE AND A POSITIVE BONNEY MANEUVER. ON DATE #2, A PARTIAL ABLATION OF THE TVT STRIP WAS PERFORMED IN ROUEN, WITH NO EROSION NOTED AT THAT TIME. SUBSEQUENTLY, ON DATE #3, THE PATIENT UNDERWENT A VAGINAL PROCEDURE DUE TO A RECURRENCE OF A VOLUMINOUS POSTERIOR COLPOCELE. DURING THIS PROCEDURE, A RICHTER'S PROCEDURE WAS AGAIN PERFORMED, AND TWO STRIPS WERE PLACED AT THE LEVEL OF THE SACROSPINOUS LIGAMENT. IT IS IMPORTANT TO NOTE THAT THE ORIGINAL TVT STRIP WAS NOT COMPLETELY REMOVED. ON DATE #4, PROLAPSE THERAPY WITH PROMONTOFIXATION WAS CONDUCTED. THE PATIENT WAS THEN REFERRED TO (B)(6) FOR MANAGEMENT OF AN INCOMPLETE ABLATION OF THE TVT STRIP, WHICH INVOLVED EROSION ON THE LEFT SIDE OF THE URETHRA UNDER THE CERVIX, LOCATED BETWEEN 4 AND 6 O'CLOCK. THIS COMPLICATION STEMMED FROM THE INCOMPLETE ABLATION OF THE TVT STRIP PLACED ON DATE #1. IT WAS PROPOSED TO PERFORM A COMPLETE ABLATION OF THE REMAINING TVT STRIP, INCLUDING ITS INTRA-URETHRAL PORTION, USING A ROBOT-ASSISTED LAPAROSCOPIC

  Patient problems: Erosion; Urinary Retention

  MAUDE report 23363587 ↗
• InjuryOct 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED PAIN, URINARY TRACT INFECTION, AND POTENTIAL URINARY RETENTION (TO BE CONFIRMED BY ULTRASOUND) AFTER TRANSURETHRAL POSITIONED SLING SURGERY. EMERGENCY STRIP REMOVED ONE MONTH AFTER INSTALLATION. THE PATIENT HAS HAD A URINARY CATHETER FOR 9 DAYS. THE PATIENT WAS DIAGNOSED WITH URINARY SPHINCTER DEFICIENCY AND WAS RECOMMENDED TO HAVE AN ARTIFICIAL URINARY SPHINCTER, WHICH WAS REJECTED."

  Patient problems: Pelvic Pain; Urinary Retention; Urinary Tract Infection

  MAUDE report 23341414 ↗
• InjurySep 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DEFECTIVE HEALING OF THE URETHRAL INCISION RESULTED IN VAGINAL EXPOSURE OF THE PROSTHESIS AT THE DELIVERY SCAR. THIS REQUIRED SURGERY IN THE OPERATING ROOM FOR SCAR RECOVERY, IN AMBULATORY SURGERY, WITH IN SOME CASES PARTIAL EXCISION OF THE STRIP.

  Patient problems: Erosion

  MAUDE report 23020540 ↗
• MalfunctionAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  "PATIENT SAYS: ELECTRIC SHOCK PAINS IN THE STOMACH (SYMPTOMS MUCH LESS AT THE TIME I MAKE THIS STATEMENT), INABILITY TO WALK FOR ABOUT 4 MONTHS, FROM THE EVENING OF THE OPERATION, TINGLING IN THE RIGHT BUTTOCK AND ALL ALONG THE RIGHT LOWER LIMB TO THE RIGHT FOOT 3 WEEKS AFTER SURGERY (SYMPTOMS MUCH LESSER AT THE TIME I MAKE THIS STATEMENT), GROIN PAIN (VERY RARE NOW), VOMITING ON DATE#1 IN THE EVENING IN HOSPITAL. PERSISTENT OR NEWER SYMPTOMS: LUMBAR AND PELVIC PAIN, RECURRENT URINARY TRACT INFECTIONS (WEEKLY) SINCE DATE#2, DYSPAREUNIA, CHRONIC VAGINAL PAIN (DEEP BURNS TYPE), "PROBABLE URETHRAL EROSION" ACCORDING TO TRANSLABIAL ULTRASOUND PERFORMED AT TENON HOSPITAL ON DATE#3, PRESENCE OF "TWO LONG WIRES WHOSE ORIGIN IS UNKNOWN" ACCORDING TO FIBERSCOPY PERFORMED AT TENON HOSPITAL ON DATE#4. IMPOSSIBILITY OF CARRYING LOADS OF MORE THAN 3 KILOGRAMS, MORE SPORTS, DIFFICULTY STANDING MORE THAN THIRTY MINUTES, DIFFICULT SEXUAL INTERCOURSE, TAKING ANTIBIOTICS VERY OFTEN (CONSEQUENCES ON MY LIVER?".

  Patient problems: Erosion

  MAUDE report 22820251 ↗
• InjuryJul 3, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2014 AND MESH WAS IMPLANTED. REPORTEDLY PROSTHETIC EXPOSURE OCCURRED IN 2021 AND HAD ATTEMPTED RECOVERY ON 2021. RECURRENCE OF PROSTHETIC EXPOSURE ON 2025. CURRENT CONDITION OF THE PATIENT: REOPERATION ON (B)(6) 2025 FOR PARTIAL EXCISION OF SUBURETHRAL STRIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abnormal Vaginal Discharge; Erosion; Pain

  MAUDE report 22396922 ↗
• InjuryJul 3, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2014 AND MESH WAS IMPLANTED. REPORTEDLY PROSTHETIC EXPOSURE OCCURRED IN 2021 AND HAD ATTEMPTED RECOVERY ON 2021. RECURRENCE OF PROSTHETIC EXPOSURE ON 2025. CURRENT CONDITION OF THE PATIENT: REOPERATION ON (B)(6) 2025 FOR PARTIAL EXCISION OF SUBURETHRAL STRIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abnormal Vaginal Discharge; Erosion; Pain

  MAUDE report 22396917 ↗
• InjuryApr 22, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2024 AND MESH WAS PLACED FOR STRESS URINARY INCONTINENCE. VAGINAL HEALING DEFECTS WERE NOTED DESPITE A REVISION FOR A COVERAGE FLAP. DURING THE OPERATION, THE SLING IS COMPLETELY VISIBLE AND EXTERNALIZED IN THE VAGINA, IN THE ANTERIOR POSITION, EXCEPT AT THE LEFT AND RIGHT ENTRY POINTS. A COLPOTOMY WAS PERFORMED, ALLOWING FOR THE RETRIEVAL OF THE SLING AT ITS RETRO-PUBIC ENTRY POINTS AND TO RESECT IT OVER MORE THAN 8 CM. A SHARED DECISION WAS MADE TO RESECT THE SLING VAGINALLY AND TO PERFORM A SUB-URETHRAL APONEUROTIC SLING. THE EXPLANTATION OF THE SUB-URETHRAL SLING WAS PERFORMED ON (B)(6), 2025. CURRENT STATUS OF THE PATIENT: EXPLANTATION OF THE SLING AND PLACEMENT OF A SUBURETHRAL APONEUROTIC SLING IN THE PATIENT UNDER GENERAL ANESTHESIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erosion

  MAUDE report 21882527 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2021 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN ON PUBIS, INSIDE VAGINA LEFT SIDE, PIRIFORM AND PUDENDAL. CONSEQUENCES OF NON-CARE, LOSS OF WORK AND DIVORCE. NON-PERMANENT PARALYSIS OF THE LEFT LEG, URINARY LEAKAGE, PSYCHOLOGICAL CONDITION AFFECTED. DEVICE WAS EXPLANTED ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE AS THE EVENT WAS REPORTED IN CONFIDENCE.

  Patient problems: Incontinence; Pain; Paresis

  MAUDE report 21778069 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT UNDERWENT A SIMPLE TAPE PROMONTOFIXATION (SACROMESH 9) BY LAPAROSCOPY ROBOT ASSISTED WITH A SUBURETHRAL TAPE TYPE MESH, FOR URETHRAL HYPER MOBILITY ASSOCIATED WITH SPHINCTER INCOMPETENCE. THIS PROCEDURE DID NOT CURE HIS INCONTINENCE, WHICH IS DEFINITELY LINKED TO SPHINCTER INCOMPETENCE. DECISION: COMPLETE REMOVAL OF THE MESH STRIP BY ALL 2 SIDES AND PLACEMENT OF ARTIFICIAL URINARY SPHINCTER IN 2 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Incontinence

  MAUDE report 21379838 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2017 AND MESH WAS IMPLANTED. SINCE THE IMPLANTATION, THE PATIENT HAS NON-STOP PAINS VERY DISABLING AND DIFFICULT TO BEAR. BURNING SENSATION DEEP TIGHTNESS OF THE LEFT GLUTEAL. SACROILLIAC MUSCLES AND PSOAS MUSCLES CONSTANTLY PULLED, PAIN, HEAVINESS AND TIGHTNESS IN THE STOMACH. URINATE EVERY 2 HOURS, AWAKE SEVERAL TIMES AT NIGHT TO URINATE WITH SENSATION THAT THE BLADDER DOES NOT COMPLETELY EMPTY, 7 YEARS OF PAIN, WANDERING, MEDICAL FATIGUE. NO MORE SPORT AS BEFORE. THE PATIENT HAS TO "CALCULATE". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burning Sensation; Pain; Urinary Frequency / Polyuria; Urinary Retention

  MAUDE report 20833084 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN 2013 AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING PAIN IN LEGS, PELVIS, VAGINA ETC. THE PATIENT FURTHER REPORTED NEUROLOGICAL PAIN, CAN NO LONGER WALK AND NO SENSATION WHEN URINATING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Neuralgia; Pain

  MAUDE report 20787911 ↗
• InjuryAug 2, 2024Appropriate 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) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HIP PAIN, FREQUENT BLEEDING, FIBROIDS, BACK PAIN, ABDOMINAL PAIN AND PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain; Prolapse

  MAUDE report 19890952 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING URINARY TRACT INFECTIONS AND CHRONIC PAIN. CURRENT STATE OF THE PATIENT: DISABILITY. NO FURTHER INFORMATION IS AVAILABLE AS THE REPORTER CONTACT DETAILS WERE NOT DISCLOSED.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 19522038 ↗