Align® TO Trans-Obturator Urethral Support System - Hook BRD400HKRecalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 00801741016219), received between Jan 2, 2013 and Nov 18, 2022 — classified as 166 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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 25 most recent of 168 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT.

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

  MAUDE report 15825641 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED,THE PATIENT EXPERIENCED BLADDER SYMPTOMS, INCOMPLETE BLADDER EMPTYING, FATIGUE, DYSURIA, RIGHT LOWER QUADRANT PAIN, URETHRAL PAIN, RIGHT INGUINAL AREA PAIN, ACUTE CYSTITIS, SPARC MESH EROSION INTO BLADDER WITH REMOVAL, SUPRAPUBIC SCARS, CANDIDA INFECTION, ABDOMINAL PAIN, PAIN ON RIGHT SIDE WITH URINATION, SUPRAPUBIC PAIN, URINARY FREQUENCY UP TO 20 TIMES PER DAY, URGENCY INCONTINENCE, GROIN PAIN WHEN SHE DRIVES, EXTERNAL IRRITATION, MILD ERYTHEMA ALONG THE SUTURE LINE OF THE BLADDER, LEVATOR MYALGIA, OVERACTIVE BLADDER, MUSCLE SPASM REQUIRING PHYSICAL THERAPY, WAKES UP AT NIGHT TO URINATE, DIFFICULTY STARTING URINATION, STRAINING, WEAK URINARY FLOW, SENSATION OF INCOMPLETE EMPTYING OF BOWELS, BLADDER INFECTIONS, VAGINAL SCARRING, BLEEDING AND PAIN WITH VAGINAL PENETRATION. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT ABDOMINAL PAIN, BURNING, DYSURIA, URINARY FREQUENCY, URINARY URGENCY, HEMATURIA, INFECTION, MESH EROSION, MESH EXTRUSION, PELVIC PAIN, RADIATING PAIN, RECURRE

  Patient problems: Adhesion(s); Anemia; Anxiety; Burning Sensation; Cellulitis; Constipation; Cramp(s) /Muscle Spasm(s); Cyst(s); Depression; Discomfort; Dysuria; Erosion; Erythema; Fatigue; Fungal Infection; Headache; Heartburn/Indigestion; Hematuria; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Incontinence; Inflammation; Micturition Urgency; Myalgia; Nausea; Nerve Damage; Pain; Prolapse; Sepsis; Skin Inflammation/ Irritation; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection; Vomiting

  MAUDE report 15066697 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 03JAN2024, THE PATIENT EXPERIENCED SEVERE PAIN, PELVIC PAIN, VAGINAL MESH EROSION, MESH EXPOSURE, VAGINAL BLEEDING, PAINFUL SEXUAL INTERCOURSE, CYSTOCELE, RECURRENT OR CHRONIC VAGINAL OR BLADDER INFECTIONS, RECURRENT VAGINAL PAIN (SHARP PAINS THAT FEEL LIKE BAD MENSTRUAL CRAMPS, IN THE LOWER ABDOMEN), URINARY INCONTINENCE, URINARY RETENTION, UTERINE PROLAPSE, VAGINAL VAULT PROLAPSE, WOUND HEALING PROBLEMS, COLLAPSED BLADDER REQUIRING ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Chest Pain; Dyspareunia; Erosion; Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Pain; Prolapse; Scar Tissue; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 12272078 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 17-JAN-2024, THE PATIENT HAD EXPERIENCED PAIN, STRESS URINARY INCONTINENCE, INFECTION, URETHRAL HYPERMOBILITY, ABDOMINAL PAIN, CONSTANT URINE LEAKAGE, LOSS OF INTIMACY, INABILITY TO EXERCISE, DIVERTICULITIS, RECURRENT OR CHRONIC VAGINAL OR BLADDER INFECTIONS, URINARY TRACT INFECTIONS, RECURRENT VAGINAL PAIN, URINARY INCONTINENCE, UTERINE PROLAPSE, AND REQUIRED ADDITIONAL SURGICAL AND NON- SURGICAL TREATMENT.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthralgia; Chills; Diaphoresis; Fever; Myalgia; Nausea; Pain; Prolapse; Sore Throat; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 12035684 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PER ADDITIONAL INFORMATION RECEIVED ON 04JUN2021, THE PATIENT EXPERIENCED VAGINAL MESH EROSION, PAIN, DYSPAREUNIA, URGE INCONTINENCE, URINARY FREQUENCY, NOCTURIA, BLEEDING, CYSTOCELE, ENTEROCELE, RECTOCELE, RECURRENT VAGINAL PAIN, URINARY INCONTINENCE, UTERINE PROLAPSE, VAGINAL ATROPHY, INCOMPLETE EMPTYING, FREQUENT URINARY TRACT INFECTIONS, HEMATURIA, KIDNEY STONES, KIDNEY PROBLEMS, VAGINAL PRESSURE, CONSTIPATION, DIARRHEA, AUTOIMMUNE DISEASE, LEG SWELLING, ARTHRALGIAS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Arthralgia; Autoimmune Disorder; Constipation; Diarrhea; Dyspareunia; Erosion; Hematuria; Hemorrhage/Blood Loss/Bleeding; Pain; Prolapse; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 11981904 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENTS ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED SUPRAPUBIC PAIN RADIATING TO THE LOWER BACK WITH BILATERAL GROIN DISCOMFORT UPON LIFTING HER SON, URINARY URGENCY, URINARY FREQUENCY, URINARY RETENTION, NOCTURIA, MILD PROLAPSE ANTERIORLY, VAGINAL AND SUPRAPUBIC PAIN, SPASMS WHICH OCCURRED WITH ACTIVITY SUCH AS MENSES, INTERCOURSE AND AT THE END OF THE DAY. SHE HAD MILD BILATERAL OBTURATOR INTERNUS DISCOMFORT AND LEFT MILD-MODERATE ILEOCOCCYGEUS TENDERNESS AND SPASM UPON PALPATION DURING EXAM. HER LATERAL PELVIC PAIN WOULD RADIATE DOWN HER LEGS, AS WELL AS TENDERNESS UPON PALPATION TO HER INNER THIGHS. ALTHOUGH SHE UTILIZED PELVIC FLOOR THERAPY FOR HTPFD, SHE UNDERWENT PROCEDURES SUCH AS A LEFT PUDENDAL BLOCK AND PERITONEAL LAPAROSCOPY WHICH DISCOVERED ENDOMETRIOSIS. SHE IS DOCUMENTED POST-IMPLANT AS HAVING RECEIVED D&C ONCE FOR ENDOMETRIOSIS. IN 2013, THE MESH WAS PALPABLE AND FELT THICKER ON THE RIGHT SIDE, AS IF IT WAS FOLDED. SHE HAD MORE TENDERNESS ON THE RIGHT SIDE OVERLYING THE SLING/PERIURE

  Patient problems: Discomfort; Injury; Micturition Urgency

  MAUDE report 11301577 ↗
• InjuryDec 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED NOCTURIA, EROSION MESH, DYSPAREUNIA, FOUL SMELLING URINE, RENAL CYST, STRESS INCONTINENCE, HEMATURIA AND AN INR OF 7.7, FLANK PAIN, INCONTINENCE, RASH ON HER LOWER LEG, ABDOMINAL PAIN (SUPRAPUBIC), BURNING IN BLADDER, INTERSTITIAL CYSTITIS, URINARY TRACT INFECTION, LEFT FLANK PAIN, NAUSEA, BACK PAIN (LEFT FLANK), HEADACHES, EPIGASTRIC PAIN, ALLERGIC REACTION, URTICARIA, PAIN IN VAGINAL AREA, SHREDDED GLASS FEELING WITH INTERCOURSE, RIB PAIN ON LEFT SIDE, VAGINAL ATROPHY, STRESS INCONTINENCE IN FEMALE, POSTOPERATIVE PAIN, VOMITING, EXPOSURE OF VAGINAL MESH THROUGH VAGINAL WALL, SCAR TISSUE, RECTUS FASCIA, INFLAMMATION. THE PATIENT REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Cyst(s); Erosion; Injury

  MAUDE report 11073819 ↗
• InjuryDec 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED YEAST INFECTION, SMALL BLOODY DISCHARGE, CANDIDAL VAGINITIS. THE PATIENT REQUIRED NON-SURGICAL INTERVENTIONS.

  Patient problems: Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 11073818 ↗
• InjuryDec 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED CONSTIPATION, MESH EXPOSURE, MESH EROSION, RECURRENT BLADDER INFECTIONS, 3 CM X 4 MM EXTRUSION OF MESH, EXTENDED SPECTRUM BETA-LACTAMASES, BURNING, URGENCY, DYSURIA, CLOUDY URINE, URINARY FREQUENCY, CYSTOCELE, GRANULOMATOUS REACTION, VAGINAL MUCOSA, EXHIBITING MILD FIBROSIS, INFLAMMATION OF THE SUBMUCOSA, MESH PAIN, RECURRENT OR WORSENING URINARY INCONTINENCE, PAIN WITH INTERCOURSE, VAGINAL (APICAL) PROLAPSE, PRESSURE, VAGINAL FULLNESS, NEEDING TO PUSH NEAR THE ANUS OR INSIDE THE VAGINA TO EVACUATE BOWEL MOVEMENTS, SLOW URINARY STREAM, TROUBLE URINATING, FREQUENCY AND OR URGENCY OF URINATION, NEEDING TO PUSH THE BLADDER IN TO URINATE, AND IRRITATION FROM PROLAPSE BEYOND THE OPENING OF THE VAGINA. THE PATIENT REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Constipation; Erosion; Injury

  MAUDE report 11073811 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED SYMPTOMATIC SLING EXTRUSION, MESH EROSION, AND REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury

  MAUDE report 11060317 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, DISABILITY AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED EROSION, MESH PROTRUDING INTO VAGINAL WALL, VAGINAL BLEEDING, PELVIC PAIN, PAIN WITH INTERCOURSE, URINARY TRACT INFECTIONS, VAGINAL DISCHARGE, UNSPECIFIED URINARY PROBLEMS, URINARY RETENTION, BLOOD LOSS, DISCOMFORT, UNSPECIFIED PROBLEMS WITH SEX LIFE, CYSTOCELE/RECTOCELE (PROLAPSE), NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED DISCOMFORT, LEFT SIDE PAIN, POSTERIOR VAGINAL MESH EROSION, DISTAL RECTOCELE, STRESS INCONTINENCE WITH INTRINSIC SPHINCTER DEFICIENCY, MESH CONTRACTURE, BLEEDING, APPROXIMATELY 4-5 CM MESH WAS DISSECTED. THE PATIENT REQUIRED ADDITIONAL SURGICAL INTERVENTIONS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 11004034 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MESH EXTRUSION, PAIN, EROSION, UNSPECIFIED BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING, BLOOD LOSS, AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED INABILITY TO VOID, MESH EROSION/EXTRUSION, PAIN, BLEEDING, HEAVINESS AND ACHING IN PELVIC AREA, WEIGHT GAIN, VAGINAL SCARRING, DYSPAREUNIA, RECURRENCE, BOWEL PROBLEM, REQUIRED NONSURGICAL INTERVENTIONS INCLUDING MEDICATIONS AND REQUIRED SURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED THE PATIENT HAS EXPERIENCED MESH EXTRUSION/EROSION, HUSBAND NOTICED EVIDENCE OF MESH DURING SEXUAL INTERCOURSE, EXCISION OF VAGINAL MESH, SLIGHTLY SLOWER STREAM, AND VAGINAL DISCHARGE. SHE HAS REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS. PER THE PLAINTIFF FACT SHEET, SHE ALLEGED THAT SHE ALSO EXPERIENCED REMOVAL OF MESH DUE TO IT NOT BEING IN THE RIGHT PLACE - MANGLED AND SHIFTED FROM THE PROPER LOCATION, CONSTANT

  Patient problems: Erosion; Injury; Pain

  MAUDE report 10928082 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 06/NOV/2020, THE PATIENT POST- IMPLANTATION COMPLICATIONS ARE UNKNOWN DUE TO THE LIMITED NUMBER OF MEDICAL RECORDS.

  Patient problems: Injury

  MAUDE report 10884835 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 30MAR2022, THE PATIENT HAS EXPERIENCED MESH EROSION, CHRONIC PAIN, VAGINAL BLEEDING, URINARY TRACT INFECTIONS, LETHARGIC, ANEMIA, DIVERTICULITIS, DYSPAREUNIA, HYPERTENSION, UTERINE PROLAPSE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Anemia; Disability; Dyspareunia; Erosion; Fatigue; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Inflammation; Injury; Pain; Prolapse; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 10513802 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED ON 24NOV2021, THE PATIENT HAS EXPERIENCED VAGINAL PROBLEM, BLEEDING AFTER INTERCOURSE, DISCOMFORT, SOMETIMES SPOTTING, MESH EROSION, HEADACHE, CHRONIC PAIN SYNDROME, ANXIETY, ECZEMA, POSTCOITAL BLEEDING, MENORRHAGIA, FAILED HYDROTHERMAL ABLATION, VAGINAL INFECTIONS, LEFT LEG AND POSS RECTAL PAIN, BROWN DISCHARGE, RECTAL OR BUTTOCK ABSCESS, NECROTIZING FASCIITIS, VAGINAL-RECTAL FISTULA, CHRONIC PAIN OF LEFT KNEE, DYSPAREUNIA, NOCTURIA, POST-MENOPAUSAL BLEEDING, URINARY URGENCY, URGE INCONTINENCE, HISPAREUNIA, LEFT UPPER EXTREMITY NUMBNESS, CHRONIC NECK PAIN, RECURRENT CARPAL TUNNEL SYNDROME, POLYARTHROPATHY, HEART BURN, SORENESS OF THE FINGERS, JOINT PAIN, POLYARTHRALGIA¿S, GASTROESOPHAGEAL REFLUX DISEASE, GALACTORRHEA, CHRONIC BACK PAIN, CHRONIC MYOFASCIAL BACK PAIN, HEMATURIA, RIGHT SIDED PELVIC PAIN, RIGHT LOWER QUADRANT ABDOMINAL PAIN, PALPITATIONS, APPENDICITIS, HEAVY BLEEDING, URINARY FREQUENCY, URINARY TRACT INFECTION, KIDNEY STONES, CONSTIPATION, UNCONTROLLED UTERINE BLEEDING, FIBROMYALGIA, VITAMIN D DEFICIENCY, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Abscess; Anxiety; Arthralgia; Constipation; Diarrhea; Disability; Discomfort; Dyspareunia; Emotional Changes; Erosion; Fasciitis; Fistula; Headache; Heartburn/Indigestion; Hematuria; Incontinence; Injury; Intermenstrual Bleeding; Micturition Urgency; Neck Pain; Nerve Damage; Numbness; Pain; Pressure Sore/Ulcer; Rectovaginal Fistula; Sepsis; Stomach Ulceration; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 10074241 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, DISABILITY AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL MESH EROSION, EXPOSURE, BACTERIAL VAGINOSIS, BLEEDING, VAGINAL DISCHARGE, BULGING SENSATION, OCCASIONAL URGENCY, RARE URINARY URGE INCONTINENCE, STAGE III + CERVICAL ELONGATION. SHE HAS REQUIRED NONSURGICAL INTERVENTIONS AND ONE SURGICAL INTERVENTION TO REMOVE VAGINAL SLING OR MESH.

  Patient problems: Blood Loss; Erosion; Micturition Urgency

  MAUDE report 9799321 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, DISABILITY AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL PAIN, GROIN PAIN, PAIN WITH INTERCOURSE/IMPAIRED SEXUAL RELATIONS, URINARY INCONTINENCE, FECAL INCONTINENCE, HEAVY BLEEDING, CHRONIC YEAST INFECTIONS, BLADDER INFECTIONS, LOW BACK PAIN, EMOTIONAL CHANGES, PRESSURE, CRAMPING, PELVIC DISCOMFORT, VOIDING BLOOD TINGED URINE (HEMATURIA), PAIN, AND REQUIRED NONSURGICAL INTERVENTIONS, DYSPAREUNIA, DRYNESS, URINARY INCONTINENCE, FATIGUE/INSOMNIA, BURNING AROUND VAGINAL AREA, VAGINAL DISCHARGE, ATROPHIC VAGINAL MUCOSA, DYSMENORRHEA, DYSPAREUNIA, DYSFUNCTIONAL UTERINE BLEEDING, DYSURIA, ENDOMETRIAL BIOPSIES, FECAL INCONTINENCE, MIXED STRESS AND URGE INCONTINENCE, DILATION AND CURETTAGE WITH HYSTEROSCOPY AND INSERTION OF MINERAL INTRAUTERINE DEVICE, ENDOMETRIAL CANCER, TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR TREATMENT OF ENDOMETRIAL CANCER, POST-COITAL BLEEDING, GRANULATION TISSUE OF VAGINAL CUFF TREATED WITH SILVER NITRATE, DECREASED ABILITY TO ORGASM, GROIN PAIN MADE WORSE BY WAL

  Patient problems: Disability; Incontinence; Pain

  MAUDE report 9750245 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGES THAT DUE TO THE DEVICE BEING IMPLANTED, THE PATIENT HAS EXPERIENCED VAGINAL PAIN, INFECTIONS, LOWER ABDOMINAL PAIN, DYSPAREUNIA, URINARY INFECTIONS, INCONTINENCE, UTEROVAGINAL PROLAPSE, GRADE THREE CYSTOCELE, LOWER LEG PAIN, BLEEDING AND ADDITIONAL SURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED THE PATIENT EXPERIENCED FREQUENCY, AND A GENITOURINARY MESH COMPLICATION WITH EXCISION OF THE MID URETHRAL MESH SLING AND REQUIRED NONSURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Pain; Unspecified Infection

  MAUDE report 9622092 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Injury

  MAUDE report 9255225 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY, AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAINFUL INTERCOURSE, INABILITY TO HOLD URINE AND PULLING IN THE HIP AREA.

  Patient problems: Disability; Incontinence; Pain

  MAUDE report 9252096 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Injury

  MAUDE report 9241619 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED ON 22NOV2021, THE PATIENT HAS EXPERIENCED DIFFICULTY IN VOIDING AND REQUIRED ADDITIONAL NON-SURGICAL INTERVENTIONS.

  Patient problems: Fever; Injury; Pain; Urinary Incontinence; Urinary Retention

  MAUDE report 9227325 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Injury

  MAUDE report 9175145 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Injury

  MAUDE report 9175138 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Injury

  MAUDE report 9163689 ↗