Align® R Retropubic Urethral Support System BRD100RRecalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 00801741016172), received between Jan 28, 2013 and Sep 9, 2026 — classified as 175 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 176 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50696500 ↗
• InjuryJun 12, 2025Adverse 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. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 22MAY2025, THE PATIENT HAD EXPERIENCED MESH EROSION, STRESS URINARY INCONTINENCE, RIGHT UPPER QUADRANT PAIN OR UPPER ABDOMINAL PAIN, BURNING SENSATION, ABNORMAL VAGINAL DISCHARGE, CONSTANT INTERMITTENT RIGHT FOOT AND ANKLE PAIN, URINARY TRACT INFECTIONS, URETHRAL STONE, CHRONIC CHOLECYSTITIS, SEPSIS, DYSURIA, FREQUENCY, HEMATURIA, URGENCY, CONSTIPATION AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Burning Sensation; Constipation; Dysuria; Erosion; Hematuria; Incontinence; Micturition Urgency; Pain; Sepsis; Urinary Frequency / Polyuria; Urinary Tract Infection; Urolithiasis

  MAUDE report 22194204 ↗
• InjuryOct 3, 2024Adverse 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. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 09-SEP-2024, THE PATIENT HAD EXPERIENCED VAGINAL MESH EXPOSURE, SUBURETHRAL PAIN AND TENDERNESS, STRESS INCONTINENCE, INTERSTITIAL CYSTITIS, MESH PAIN, INTRINSIC SPHINCTER DEFICIENCY, LEVATOR SPASM, PELVIC PAIN, DYSPAREUNIA, SEVERE CRAMPING LOCK PAIN, ABDOMINAL HERNIA, MENORRHAGIA , BLADDER DISCOMFORT , URINARY TRACT INFECTION, DYSURIA, FLANK PAIN (RIGHT), FREQUENCY, HEMATURIA AND URGENCY, NAUSEA, VOMITING, DIARRHEA, PELVIC HEMATOMA, EROSION OF VAGINAL MESH, ARTHRITIS, DEPRESSION, SLEEP PROBLEMS, ARRYTHMIA, URINARY LEAKAGE, ANKYLOSING SPONDYLITIS, FATIGUE, MOUTH SORES, VAGINAL DISCHARGE, VAGINAL PAIN, JOINT SWELLING, TENDERNESS, BACK PAIN, NECK PAIN, RASH, HEADACHE, WEAKNESS, DIZZINESS, NUMBNESS, TINGLING, BRUISING, CARCINOID TUMOR OF APPENDIX BENIGN, CHRONIC PAIN, HEARING LOSS, INFLAMMATORY BOWEL DISEASE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Burning Sensation; Cramp(s) /Muscle Spasm(s); Dehydration; Depression; Diarrhea; Discomfort; Dizziness; Dyspareunia; Dysuria; Erosion; Fatigue; Headache; Heartburn/Indigestion; Hematoma; Hematuria; Hernia; Hypokalemia; Hypothyroidism; Incontinence; Interstitial Cystitis; Menorrhagia; Micturition Urgency; Myalgia; Nausea; Numbness; Pain; Partial Hearing Loss; Rash; Stenosis; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 20359810 ↗
• InjuryAug 21, 2024Adverse 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. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 24-JUL-2024, THE PATIENT HAD EXPERIENCED VAGINAL BLEEDING, STRESS URINARY INCONTINENCE, DYSPAREUNIA, BLADDER SLING MESH EROSION, CHRONIC FATIGUE, DIARRHEA, DYSPEPSIA, INSOMNIA, GASTROINTESTINAL BLEED, THYROID CANCER, INTERMITTENT SPOTTING, ABDOMINAL PAIN, ADJUSTMENT DISORDER, C. DIFFICILE COLITIS, HYPERPLASTIC POLYP OF SIGMOID COLON, ANXIETY, HEARTBURN, MIGRAINES, NUMBNESS AND TINGLING, SHORTNESS OF BREATH, SNORES, SUBSTANCE ABUSE, THYROID CANCER, BLADDER INCONTINENCE, DYSURIA, FREQUENCY, NOCTURIA, PELVIC PAIN, ABNORMAL VAGINAL DISCHARGE, BRIGHT RED AND BROWN COLOR URINE VOIDING, FATIGUE, LEG SWELLING, HOT FLASHES, DEPRESSION , SLEEP DISTURBANCES, ARTHRALGIAS, LOWER GASTROINTESTINAL BLEED, PINK TO BRIGHT RED BLOOD STOOLS, ANAL BLEEDING, ABDOMINAL TENDERNESS, ITCHING, YEAST INFECTION, TROUBLE SWALLOWING, VOMITING AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Diarrhea; Dyspareunia; Dysphagia/ Odynophagia; Dysuria; Erosion; Fatigue; Fungal Infection; Gastrointestinal Hemorrhage; Genital Bleeding; Heartburn/Indigestion; Incontinence; Itching Sensation; Numbness; Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Vomiting

  MAUDE report 20010203 ↗
• InjuryAug 20, 2024Adverse 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. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 24-JUL-2024, THE PATIENT HAD EXPERIENCED ABDOMINAL SWELLING, BLOATING, LOWER ABDOMINAL PAIN, DIARRHEA, HOT FLASHES, CHEST PAIN, ANXIETY, WATER RETENTION IN LEGS, STABBING PAIN IN RIGHT BUTTOCK, CHRONIC MIGRAINE HEADACHE, JAW PAIN, CHRONIC PELVIC PAIN, VAGINAL BLEEDING, ABNORMAL BROWNISH GREEN DISCHARGE, LESION OF VULVA, PAIN IN VULVA, INCONTINENCE, DIFFICULTY URINATING, URINARY FREQUENCY, NERVE PAIN, IRRITABLE BOWEL SYNDROME, INTERSTITIAL CYSTITIS, DEEP CONNECTIVE TISSUE DYSFUNCTION, INFLAMMATION, PROLAPSE, MESH EROSION, FLAREUPS, BLADDER STINGING AND BURNING, HIKING, STRAIN OF NECK MUSCLE, BACK STRAIN, NECK SWELLING, HEMATURIA, DYSPAREUNIA, RECTOCELE, DYSURIA, ACUTE URINARY TRACT INFECTION, METRORRHAGIA, HOT FLASHES, NIGHT SWEATS, SINUS PAIN, CONGESTION, RASH ON LEFT EYE, EYE IRRITATION, COUGH, KNEE PAIN, FOLLICULITIS, POST COITAL BLEEDING, DERMATITIS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Dyspareunia; Dysuria; Erosion; Eye Irritation; Genital Bleeding; Headache; Hematuria; Incontinence; Inflammation; Pain; Prolapse; Rash; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 20008434 ↗
• InjuryDec 22, 2023Adverse 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, IMPAIRMENT. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 01DEC2023 THE PATIENT EXPERIENCED MESH EROSION AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

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

  MAUDE report 18382617 ↗
• InjuryJul 20, 2023Adverse 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, IMPAIRMENT.

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

  MAUDE report 17358630 ↗
• InjuryJun 2, 2023Adverse 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, IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON (B)(6)2023, THE PATIENT HAS EXPERIENCED EXTREME PAIN, KNOTS AND SWELLING IN PELVIC AREA, FEVER/CHILLS, ANXIETY, EMOTIONAL DAMAGE, PROLAPSE, URINARY FREQUENCY, VULVAR ABSCESS, WOUND VAC PLACED, MESH INFECTION, CELLULITIS, SEPSIS, CHRONIC ANEMIA, LEUKOCYTOSIS, CYSTOCELE, CANCER, FISTULAS, PELVIC TUMORS OR FIBROIDS, RECTOCELE, RECURRENT VAGINAL PAIN, URINARY INCONTINENCE, URINARY RETENTION, UTERINE PROLAPSE, VAGINAL VAULT PROLAPSE, HYPERTENSION, MICROSCOPIC HEMATURIA, NEPHROLITHIASIS, NON ST ELEVATED MYOCARDIAL INFARCTION, BLADDER TUMOR, EROSION OF VAGINAL MESH, VAGINAL PROLAPSE, DYSURIA, PAPILLARY THYROID CARCINOMA, HYPOTHYROIDISM, BILATERAL OVARIAN CYST, ENDOMETRIOSIS, OVERACTIVE BLADDER, LEVATOR SPASM, ADNEXAL MASS, INTRA-ABDOMINAL INFECTION, VIRAL DISEASE, BLADDER PAIN, BLADDER SPASMS, MUSCLE WEAKNESS, CUTANEOUS ABSCESSES, PELVIC ABSCESSES, HYPOKALEMIA, DEEP POST-OPERATIVE WOUND INFECTION, INTRA-ABDOMINAL INFECTION, LIPID SCREENING, KIDNEY STONES, MYOCARDIAL INFARCT

  Patient problems: Abscess; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cancer; Cellulitis; Cramp(s) /Muscle Spasm(s); Cyst(s); Dysuria; Emotional Changes; Erosion; Fever; Fistula; Hematuria; High Blood Pressure/ Hypertension; Hypokalemia; Muscle Weakness/Atrophy; Myocardial Infarction; Pain; Prolapse; Sepsis; Swelling/ Edema; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 17049971 ↗
• InjuryJan 13, 2023Adverse 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, IMPAIRMENT. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS. ON (B)(6) 2023 THE PATIENT EXPERIENCED PAIN, URINARY TRACT INFECTION, SWELLING, BLADDER CALCULUS, ASYMPTOMATIC MICROSCOPIC HEMATURIA, DYSURIA, SHIVERING, HYPOTENSION, FREQUENCY OF MICTURITION, URGE INCONTINENCE, URGE URINATION, NAUSEA, VOMITING, CONSTIPATION, URINARY RETENTION AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

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

  MAUDE report 16156982 ↗
• InjuryAug 25, 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.

  Patient problems: Discomfort; Pain

  MAUDE report 15293028 ↗
• InjuryJul 29, 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. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON (B)(6) 2022, THE PATIENT HAS EXPERIENCED EROSION OF IMPLANTED URETHRAL MESH TO SURROUNDING ORGAN OR TISSUE, PELVIC PAIN, BLADDER PAIN, RECURRENT BLADDER STONES, MIGRATION AND EMBEDDED MESH, RECURRENCE OF STRESS URINARY INCONTINENCE, DISCOMFORT, URINARY TRACT INFECTION, CANCER, PELVIC TUMORS OR FIBROIDS, RECURRENT OR CHRONIC VAGINAL OR BLADDER INFECTIONS, RECURRENT VAGINAL PAIN AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Cancer; Constipation; Cramp(s) /Muscle Spasm(s); Depression; Discomfort; Erosion; Fatigue; Hematuria; Incontinence; Pain; Prolapse; Urinary Tract Infection

  MAUDE report 15128527 ↗
• InjuryMay 4, 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 INJURY, PAIN, DISABILITY AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON (B)(6) 2022, THE PATIENT HAS EXPERIENCED CHRONIC RECURRENT URINARY TRACT INFECTIONS, PAINFUL SEXUAL INTERCOURSE, DIFFICULTY IN EMPTYING BLADDER, PARTIAL URINARY RETENTION, OCCASIONAL DIFFICULTY INITIATING VOIDING, VAGINAL BURNING AND BURNING SENSATION WHEN URINATING, DIFFICULTY HOLDING URINE, DYSPAREUNIA, ENTEROCELE, RECTOCELE, URINARY INCONTINENCE, URINARY RETENTION, UTERINE PROLAPSE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Dyspareunia; High Blood Pressure/ Hypertension; Micturition Urgency; Prolapse; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 14278805 ↗
• InjuryDec 8, 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 (B)(6) 2021, THE PATIENT HAS EXPERIENCED MESH EROSION OF SUB URETHRAL SLING TAPE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion

  MAUDE report 12960179 ↗
• InjuryDec 8, 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.

  Patient problems: Unspecified Infection

  MAUDE report 12960178 ↗
• InjuryDec 8, 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 22NOV2021, THE PATIENT HAS EXPERIENCED URINARY RETENTION, MESH EROSION INTO THE URETHRA, STRESS URINARY INCONTINENCE, RECTAL PROLAPSE, DIFFICULTY IN VOIDING, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Prolapse; Urinary Incontinence; Urinary Retention

  MAUDE report 12960175 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS BEING OPENED IN ASSOCIATION WITH THE ALLEGED EVENT FILED BY THE PATIENT¿S ATTORNEY IN COMPLAINT NUMBER (B)(4). THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THIS DEVICE IS LISTED IN THE PATIENT¿S OPERATIVE RECORD. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, INFECTION, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, SUPERFICIAL PERIURETHRAL/VAGINAL WALL LACERATIONS (VAGINAL MUCOSAL DAMAGE), HYPERTENSION, BRUISING AND DECREASED HEMOGLOBIN LEVELS. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, THE HAS EXPERIENCED VAGINAL PAIN, DYSPAREUNIA, CYSTITIS, NODOSA, MODERATE TRABECULATION, PALPABLE TRANSVERSE SCAR AT THE LEVEL OF MIDURETHRA AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Bruise/Contusion; Cyst(s); Dyspareunia; High Blood Pressure/ Hypertension; Laceration(s); Pain; Scar Tissue; Vaginal Mucosa Damage

  MAUDE report 12927004 ↗
• InjuryDec 3, 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 15NOV2021, THE PATIENT HAS EXPERIENCED MESH EXPOSURE OR EROSION THROUGH THE VAGINAL WALL, VAGINAL BLEEDING, VOIDING DYSFUNCTION, PALPITATIONS, PAIN, INFECTION, URINARY PROBLEMS, ACQUIRED HYPOTHYROIDISM UNSPECIFIED, HEART DISEASE, HYPERTENSION, ARTHRITIS, GASTROESOPHAGEAL REFLUX, THYROID DISEASE, RHEUMATIC TRICUSPID VALVE DISEASE, CHRONIC HYPERLIPIDEMIA, POSTOPERATIVE NAUSEA AND VOMITING, MOTION SICKNESS, POSTMENOPAUSAL BLEEDING, VIRAL DISEASE, SPOTTING, SKIN CANCER, SLEEP APNEA, ARRHYTHMIA, TRANSFUSION, VAGINAL SWELLING, ANEMIA, HEMATURIA, ATROPHIC VAGINITIS, SIMPLE CORTICAL AND PARAPELVIC CYSTS, IRRITABLE LOWER URINARY TRACT SYMPTOMS, PELVIC PRESSURE, HARD STOOLS, CONSTIPATION, URETHRAL POLYP, MID URETHRAL PROLAPSE, INTERMITTENT SWELLING OF THE LEFT LABIA MAJORA, URINARY FREQUENCY, DISCOMFORT WHILE URINATION, HEART MURMUR, SCIATICA, SHORTNESS OF BREATH, OVERACTIVE BLADDER, FLANK PAIN, NOCTURIA, URINARY URGENCY, FOUL SMELL OF URINE, URINARY TRACT INFECTION, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTI

  Patient problems: Anemia; Apnea; Arrhythmia; Arthritis; Cancer; Constipation; Cyst(s); Discomfort; Dyspnea; Erosion; Hematuria; High Blood Pressure/ Hypertension; Intermenstrual Bleeding; Micturition Urgency; Nausea; Pain; Prolapse; Swelling/ Edema; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Tract Infection; Vomiting

  MAUDE report 12922964 ↗
• InjuryDec 2, 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 12NOV2021, THE PATIENT HAS EXPERIENCED ANEMIA, TOBACCO USE DISORDER, MESH COMPLICATIONS, PAIN DURING SEXUAL INTERCOURSE, PELVIC MYOFASCIAL PAIN, VAGINAL BULGE, PELVIC PRESSURE SYMPTOMS, URINARY LEAKAGE, URGE INCONTINENCE, URINARY URGENCY, URINARY FREQUENCY, INCOMPLETE EMPTYING THE BLADDER, URINARY TRACT INFECTIONS, BOWEL SYMPTOMS, CHRONIC CONSTIPATION, HEMATOCHEZIA ATTRIBUTED TO ISCHEMIC COLITIS, DYSPAREUNIA, WEIGHT LOSS, CHRONIC BACK PAIN, PALPABLE AREA OF LEFT URETHRA ON THE ANTERIOR VAGINAL WALL, MIXED URINARY INCONTINENCE, FATIGUE, NAUSEA, DARK VAGINAL DISCHARGE, BLEEDING, ABDOMINAL PAIN, DIFFICULTY IN MICTURITION, LOSS OF APPETITE, VAGINAL WOUND SEPARATION, LOW GRADE TEMPERATURE, FOUL ODOR, URINARY BURNING SENSATION, VAGINAL ITCHING, SORES IN MOUTH AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Alteration in Body Temperature; Anemia; Burning Sensation; Constipation; Fatigue; Intermenstrual Bleeding; Ischemia; Itching Sensation; Micturition Urgency; Nausea; Pressure Sore/Ulcer; Urinary Tract Infection; Weight Changes

  MAUDE report 12915215 ↗
• InjuryNov 3, 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. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON (B)(6) 2021, THE PATIENT HAS EXPERIENCED PARTIAL OUTLET URETHRAL OBSTRUCTION, STRESS URINARY INCONTINENCE, OCCASIONAL URGE INCONTINENCE, TISSUE PERFORATION, SKIN INTEGRITY, ANXIETY, ALTERED BODY TEMPERATURE, INCOMPLETE EMPTYING OF BLADDER, URINARY LEAKAGE, NAUSEA, CERVICAL SPONDYLOSIS, BLURRY VISION, OVERWEIGHT, INSOMNIA, METRORRHAGIA, DYSPNEA, CHRONIC RHINITIS, CHRONIC SINUSITIS, URINARY FREQUENCY, NOCTURIA, DROWSINESS, RESTLESS LEG SYNDROME, FATIGUE, PAIN IN RIGHT SHOULDER JOINT, MILD OBSTRUCTIVE SLEEP APNEA, RIGHT KNEE PAIN AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Alteration in Body Temperature; Anxiety; Apnea; Blurred Vision; Dyspnea; Fatigue; Incontinence; Micturition Urgency; Nausea; Obstruction/Occlusion; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 12743583 ↗
• InjuryOct 27, 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.

  Patient problems: Unspecified Infection

  MAUDE report 12703461 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS BEING OPENED IN ASSOCIATION WITH THE ALLEGED EVENT FILED BY THE PATIENT¿S ATTORNEY IN COMPLAINT NUMBER (B)(4). THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THIS DEVICE IS LISTED IN THE PATIENT¿S LITIGATION. PER ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 14, 2019, THE PATIENT HAS EXPERIENCED RECURRENT MECHANICAL DYSFUNCTION OF THE GENITOURINARY DEVICE, SCAR TISSUE, RECURRENT GRANULATION TISSUE, RECURRENT VAGINAL POLYPS, SLOWING OF THE URINARY STREAM, URINARY URGENCY, POLYPOID REACTIVE GRANULATION TISSUE, VAGINAL FOREIGN BODY, AND GRANULOMA. SHE HAS REQUIRED MULTIPLE NON-SURGICAL INTERVENTIONS AS WELL AS MULTIPLE SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED ON 11OCT2021, THE PATIENT HAS EXPERIENCED RECURRENT VAGINAL POLYPS, VAGINAL GROWTH, URINARY URGENCY, VAGINAL ATROPHY, URGE INCONTINENCE, BURNING SENSATION WHILE URINATION, URINARY LEAKAGE, PAIN WHILE WALKING, VAGINAL BLEEDING, MIXED INCONTINENCE, VAGINAL DISCHARGE, RECURRENT STRESS URINARY INCONTINENCE, VAGINAL SPOTTING, RECURRENCE OF VAGINAL GRANULATION TISSUE, DISCOMFORT IN THE VAGINAL AREA, PELVIC PAIN, OVERACTIVE BLADDER SYNDROME, NOCTURIA, VAGINAL FOREIG

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Burning Sensation; Discomfort; Dyspareunia; Foreign Body In Patient; Granuloma; Hernia; Intermenstrual Bleeding; Micturition Urgency; Pain; Scar Tissue; Urinary Incontinence

  MAUDE report 12688277 ↗
• InjuryOct 19, 2021Adverse 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. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED ON 11OCT2021, THE PATIENT HAS EXPERIENCED ABDOMINAL PAIN, CELLULITIS AND ABSCESS OF TRUNK, WEIGHT LOSS, NAUSEA, BLOOD IN STOOLS, SUPRAPUBIC DISCOMFORT, SWELLING, LOW GRADE FEVER, SEVERE PRESSURE IN ABDOMEN, TENDERNESS, VAGINAL BLEEDING, MESH PALPITATIONS IN THE SUPRAPUBIC AREA TO THE LEFT IN THE MIDLINE, CHRONIC URINARY FREQUENCY, NOCTURIA, FOLLICULITIS ON THE SKIN, MESH INFECTION, MESH EROSION, FATIGUE, LUMP AROUND LEFT SUPRAPUBIC AREA, INTRAABDOMINAL ADHESIONS, POSTERIOR VAGINAL WALL PROLAPSE, CHILLS, SEVERE ANXIETY, ABSCESS IN RETROPUBIC AREA EXTENDING INTO BLADDER WALL, CHRONIC PAIN, ARTHRITIS, LOW BACK PAIN, LUMBOSACRAL NEURITIS, VAGINAL PAIN, BUMP ON GROIN AREA, URINARY TRACT INFECTION, LOSS OF APPETITE, SNEEZING, COUGH, MESH MIGRATION, CHRONIC INFECTIONS, DYSPAREUNIA, BLADDER INFECTIONS, UTERINE PROLAPSE, PAIN DURING THE SEXUAL INTERCOURSE, FIBROMYALGIA, RECURRENT PELVIC ORGAN PROLAPSE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INT

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Anxiety; Arthritis; Chills; Discomfort; Dyspareunia; Erosion; Fatigue; Fever; Intermenstrual Bleeding; Nausea; Pain; Prolapse; Sneezing; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Tract Infection; Weight Changes

  MAUDE report 12655568 ↗
• InjuryAug 26, 2021Adverse 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: Adhesion(s); Bronchitis; Constipation; Discomfort; Pain; Prolapse; Swelling/ Edema; Transmissible Spongiform Encephalopathy(TSE); Urinary Incontinence; Urinary Retention

  MAUDE report 12373937 ↗
• InjuryAug 10, 2021Adverse 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: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Erosion; High Blood Pressure/ Hypertension; Incontinence; Pain

  MAUDE report 12303077 ↗
• InjuryAug 9, 2021Adverse 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 ON 21JUL2021, THE PATIENT HAS EXPERIENCED MESH EROSION, VAGINAL PAIN AND PRESSURE, DYSPAREUNIA, VAGINAL PROLAPSE, STRESS URINARY INCONTINENCE WORSENED, URETHRAL STONE, LOSS OF QUALITY OF LIFE, ANXIETY, DEPRESSION, EMBARRASSMENT DUE TO USING INCONTINENCE PADS CONTINUOUSLY, URGE INCONTINENCE, DIFFICULTY IN STOPPING THE URINE FLOW, CYSTOCELE, RECTOCELE, PAIN DURING SEXUAL INTERCOURSE, UTERINE PROLAPSE, ANEMIA, URINARY TRACT INFECTION, VAGINAL INFECTION, ABNORMAL PAP SMEAR OF CERVIX, INFERTILITY AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Anemia; Dyspareunia; Erosion; Micturition Urgency; Pain; Prolapse; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 12293721 ↗