Alyte™ Y-Mesh Graft Y500Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00801741016165), received between Oct 24, 2013 and Nov 5, 2025 — classified as 72 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Corroded” (5 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 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3MM MESH EXTRUSION ON POSTERIOR WALL VAGINA. MRI PELVIS REQUESTED AND STARTING VAGINAL OESTROGEN.

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

  MAUDE report 23476928 ↗
• InjuryMay 2, 2024Adverse 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 18-NOV2024, THE PATIENT HAD EXPERIENCED UTEROVAGINAL PROLAPSE, BOWEL OBSTRUCTION, THIRD DEGREE RECTOCELE, SECOND DEGREE CYSTOCELE, EXTERNAL HEMORRHOID, RECTOVAGINAL FISTULA, VULVODYNIA, MIGRAINES, CHRONIC INTERSTITIAL CYSTITIS, ABDOMINAL PAIN, DYSURIA, DYSPAREUNIA, URINARY FREQUENCY, NOCTURIA, URINARY URGENCY, COLITIS, TRIGEMINAL NEURALGIA, YELLOWISH DISCHARGE FROM VAGINA, LEAKAGE, OSTEOARTHRITIS, SCOLIOSIS, DISCOMFORT TO THE EPIGASTRIC AREA AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Discomfort; Dyspareunia; Dysuria; Interstitial Cystitis; Micturition Urgency; Neuralgia; Obstruction/Occlusion; Pain; Prolapse; Rectovaginal Fistula; Urinary Frequency / Polyuria

  MAUDE report 19229723 ↗
• InjuryApr 17, 2023Adverse 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 PAIN, RECURRENCE, ABDOMINAL DISCOMFORT, NAUSEA, ELEVATED TEMPERATURE, RIGHT LOWER QUADRANT PAIN, ADHESIONS, NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 24MAR2023, THE PATIENT HAS EXPERIENCED CHRONIC PAIN, DYSPAREUNIA, SCARRING, INFECTIONS, DISABILITY, AND REQUIRED ADDITIONAL NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nausea; Scar Tissue; Unspecified Infection

  MAUDE report 16758924 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN WHILE USING ALYTE Y-MESH GRAFT. IT WAS STATED THAT THE MESH WAS TOTALLY REMOVED.

  Patient problems: Pain

  MAUDE report 16512987 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ALYTE Y-MESH GRAFT EXPOSURE AT VAGINAL VAULT. THE PATIENT UNDERWENT LAPAROSCOPIC SACROCOLPOPEXY AND CYSTOSCOPY AND EXPERIENCED DYSPAREUNIA AND PAIN IN THE VAGINA.

  Patient problems: Dyspareunia; Pain

  MAUDE report 13102533 ↗
• InjuryDec 13, 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 12982640 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED ON 27JUN2022, THE PATIENT EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bowel Perforation; Cancer; Depression; Hematuria; Hernia; Micturition Urgency; Muscle Weakness/Atrophy; Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 12422631 ↗
• InjuryDec 28, 2020Adverse 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 ABNORMAL VAGINAL BLEEDING, SUBARACHNOID HEMORRHAGE, EROSION, AND PAIN. THE PATIENT REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Hemorrhage, Subarachnoid; Injury; Intermenstrual Bleeding

  MAUDE report 11078386 ↗
• 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 MESH EROSION AND PELVIC PAIN, PAIN, INCONTINENCE, LEAKAGE IS PREDOMINANTLY WITH URGENCY, NOCTURIA, EROSION OF OTHER IMPLANTED MATERIAL TO SURROUNDING TISSUE, INITIAL ENCOUNTER, STRESS INCONTINENCE, FEMALE, MUSCLE SPASM, MIDLINE CYSTOCELE, ATROPHIC VAGINITIS, FREQUENCY, POSITIVE FOR BACK PAIN, DEPRESSION, MILD ERYTHEMA, URGE AND STRESS INCONTINENCE, CYSTOCELE, RECTOCELE, ENTEROCELE. THE PATIENT REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury; Pain

  MAUDE report 11073817 ↗
• InjuryNov 19, 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, THE PATIENT HAS EXPERIENCED ABDOMINAL PAIN, MESH EXPOSURE, MESH EROSION, TENDERNESS AND PALPITATION OVER POSTERIOR VAGINAL MESH, AND THE PATIENT REQUIRED SURGICAL AND NON-SURGICAL INTERVENTION.

  Patient problems: Abdominal Pain; Erosion; Injury

  MAUDE report 10868298 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 26AUG2022, THE PATIENT HAS EXPERIENCED CHRONIC PAIN, ABSCESS, LOWER BACK PAIN, URINARY TRACT INFECTION, CYSTOCELE, DIABETES, DYSPAREUNIA, HYPERTENSION, SEPSIS, RECTOCELE, URINARY INCONTINENCE, URINARY RETENTION, UTERINE PROLAPSE, LUMBOSACRAL RADICULOPATHY, DIZZINESS, MUSCLE CRAMP, BACK PAIN, SENSORY NEUROPATHY, CHRONIC BILATERAL LOW BACK PAIN WITH RIGHT-SIDED SCIATICA, VERTIGO, HYPERREFLEXIA, GAIT DIFFICULTY, OTALGIA, LEFT LEG NUMBNESS, INFECTION OF LAPAROSCOPIC SACRAL COLPOPEXY MESH, ENDOMETRIOSIS OF UTERUS, PROLAPSE OF GENITAL ORGANS, ATROPHIC VAGINITIS, INCREASED FREQUENCY OF URINATION AND ENDOMETRIUM THICKENED AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Anxiety; Bacterial Infection; Cramp(s) /Muscle Spasm(s); Depression; Disability; Dizziness; High Blood Pressure/ Hypertension; Incontinence; Injury; Neuropathy; Numbness; Pain; Pelvic Inflammatory Disease; Prolapse; Sepsis; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection; Vertigo

  MAUDE report 10254149 ↗
• InjuryJun 9, 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, THE PATIENT HAS EXPERIENCED PAIN, LOW RED BLOOD CELLS/HEMATOCRIT/HEMOGLOBIN AND NONSURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED SCARRING (SCAR TISSUE), EROSION, PAIN, DEPRESSION, PAIN WITH INTERCOURSE, ANXIETY, BLOATING, VAGINAL/GROIN PAIN, INTERNAL PAIN, FOREIGN BODY IN PATIENT, ABDOMINAL PAIN, INABILITY TO HAVE INTERCOURSE, AMBULATION DIFFICULTIES, ADHESIONS, UNSPECIFIED BOWEL PROBLEMS, DYSPAREUNIA, INCONTINENCE, LOW RED BLOOD CELLS/HEMATOCRIT/HEMOGLOBIN, URETERAL STRICTURE (OBSTRUCTION), ENTEROCELE (PROLAPSE), BLOOD LOSS, INFLAMMATION, FIBROSIS, FOREIGN BODY REACTION, NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury; Pain

  MAUDE report 10135556 ↗
• InjuryMar 24, 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 VIA MEDICAL RECORDS, THE PATIENT HAS EXPERIENCED A PALPABLE SLING AND SUTURES, SLING MESH EROSION, VAGINAL EROSION OF MIDURETHRAL SLING, MIDLINE CYSTOCELE, URGENCY OF URINATION, UTERINE PROLAPSE, RECURRENT SLING EXPOSURE, ATROPHY, POOR HEALING, MESH CONTRACTURE, INTERSTITIAL CYSTITIS, PUDENDAL NEURALGIA, DYSPAREUNIA, STRESS URINARY INCONTINENCE, MESH REJECTION, PELVIC PAIN, TRIGGER POINT INJECTIONS, AND PLACEMENT OF RECTUS FASCIA AUTOLOGOUS SLING. THE PATIENT REQUIRED MULTIPLE SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury; Prolapse

  MAUDE report 9872308 ↗
• InjuryMar 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, BRUISING AROUND UMBILICUS, FAILED VOIDING TRIAL, POST VOID RESIDUAL (URINARY RETENTION), SINUS BRADYCARDIA, UNABLE TO VOID, FOLEY CATHETER RE-INSERTION, BURNING PAIN (BURNING SENSATION), URINARY INCONTINENCE, BACK PAIN, CYSTOCELE (PROLAPSE), PESSARY USE, RIGHT LEG TINGLING SENSATION, PELVIC PAIN, DYSURIA, FEELS SHE CAN¿T EMPTY BLADDER ALL THE WAY, HIP PAIN, BLOOD IN URINE, INFLAMMATION, PROBLEMS WALKING (AMBULATION DIFFICULTIES), HEADACHES, INCISIONAL PAIN, PURULENT DRAINAGE, CANDIDIASIS (FUNGAL INFECTION), CELLULITIS (BACTERIAL INFECTION) AND NONSURGICAL INTERVENTIONS, PAIN, INFECTION, URINARY PROBLEMS, URINARY INCONTINENCE, RECURRENCE, ANXIETY DISORDER AND MANIA, BIPOLAR, MOOD SWINGS, CHRONIC PAIN SYNDROME, DIABETES MELLITUS TYPE 2, HYPERGLYCEMIA, CHRONIC OBSTRUCTIVE DISEASE/RESTRICTIVE LUNG DISEASE (COPD), JOINT PAIN/RIGHT HIP PAIN/POLYARTHRALGIAS (JOINT PAIN), SCIATICA, HIP/BACK PAIN, HYPERLIPIDEMIA/HYPERCHOLESTEROLEMIA, INSOMNIA, ELEVATED BLOOD PRESSURE/HYPERTENSION, SWOLLEN GLANDS/SORE THROAT, STOMACH SPASMS, RIGHT LEG TINGLING SENSATION (TING

  Patient problems: Bruise/Contusion; Injury; Pain

  MAUDE report 9866238 ↗
• InjuryFeb 28, 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, IMPAIRMENT PER ADDITIONAL INFORMATION RECEIVED THE PATIENT EXPERIENCED PERIURETHRAL PAIN, DYSPAREUNIA, APICAL VAGINAL PAIN, LEVATOR MYALGIA, FREQUENCY OF URINATION, STRESS URINARY INCONTINENCE, RIGHT AND LEFT LOWER ABDOMINAL PAIN, CYSTOCELE, LAPAROSCOPIC ADHESIOLYSIS, SLING REMOVAL, MESH REMOVAL, PARAVAGINAL REPAIR, LAPAROSCOPIC BURCH PROCEDURE, SUPRAPUBIC PELVIC PAIN, URINE LEAKAGE, INTRINSIC SPHINCTER DYSFUNCTION, STRICTURE AND ATRESIA OF VAGINA, URGENCY OF URINATION, NOCTURIA, FEELING OF INCOMPLETE BLADDER EMPTYING, GENERALIZED INTRA-ABDOMINAL AND PELVIC SWELLING, MASS AND LUMP, RIGHT UPPER AND LOWER QUADRANT PAIN, ABDOMINAL DISTENTION, URGE INCONTINENCE, KIDNEY INFECTION, SHORTENED VAGINA, SEVERE PAIN AT THE APEX, PERINEAL ABSCESS, RETROPERINEAL FIBROSIS ON THE LEFT PELVIC SIDEWALL, LEFT URETEROLYSIS, ADHESIONS, PLACEMENT OF URETERAL STENT, LARGE AMOUNT OF FIBROSIS AND ADHESIVE TISSUE AT LEFT OVARY, PELVIC SCAR TISSUE WITH REMOVAL, LAPAROSCOPIC NEOVAGINA, LEFT OVARY REMOVAL, PERINEAL BODY MASS REMOVAL, HEMATOMA, URINARY TRACT INFECTIO

  Patient problems: Disability; Injury; Pain

  MAUDE report 9770161 ↗
• InjuryJan 23, 2020Adverse 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 REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Injury

  MAUDE report 9622094 ↗
• InjuryJan 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.

  Patient problems: Injury

  MAUDE report 9622085 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INSERTION OF BARD ALYTE Y MESH TAPE AT THE HOSPITAL ON (B)(6) 2011. PER ADDITIONAL INFORMATION RECEIVED THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE, WEAK PELVIC FLOOR, TOTAL PELVIC ORGAN PROLAPSE (CYSTOCELE), URINARY RETENTION, FREQUENCY, INJURY, SLEEP DISTURBANCE, CHRONIC GROIN PAIN, ABDOMINAL PAIN, PROLAPSED BOWEL CONSTIPATION, LIMB PAIN, RECTOPEXY, SACRAL COLPEXY, BOWEL RESECTION, EROSION, CONTRACTIONS, INFECTIONS, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC, NERVE DAMAGE, PAIN, FECAL INCONTINENCE AND ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Incontinence; Injury; Prolapse

  MAUDE report 9503627 ↗
• InjuryNov 8, 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 9297351 ↗
• InjuryNov 8, 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 9297348 ↗
• 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MESH EXPOSURE FROM THE TOTAL PROLIFT AND TVT, VAGINAL PAIN, BLOODY BROWN VAGINAL DISCHARGE, DYSPAREUNIA, VAGINAL ODOR, DIFFICULTY VOIDING, VAGINAL WALL PROLAPSE, OLD LACERATION OF MUSCLES OF PELVIC FLOOR, URINARY RETENTION, ABDOMINAL PAIN, CONSTIPATION, DIARRHEA, INCOMPLETE EMPTYING, NOCTURIA, FREQUENCY, STRESS AND URGE INCONTINENCE, KINK OF URETHRAL MEATUS, ATTENUATED PERINEUM, VAGINAL SCARRING, ANTERIOR MESH EXPOSURE, HYPERMOBILE BLADDER NECK, CORDS OF MESH, FOREIGN BODY IN VAGINA-EXPOSED MESH, SEVERE SCARRING IN EVERY SPACE AND SEGMENT OF THE PELVIC FLOOR, ANTERIORLY, POSTERIORLY, LATERALLY AS WELL AS UNDER THE URETHRA, ERODED SLING MESH, PER PATHOLOGY-SYNTHETIC MESH MATERIAL WITH CHRONIC INFLAMMATION, FOREIGN-BODY GIANT CELL REACTION, AND FIBROSIS, WITH FOCAL ACUTE INFLAMMATION, SURGICAL AND NONSURGICAL INTERVENTIONS INCLUDING, BILATERAL PARAVAGINAL DISSECTION, BILATERAL PARARECTAL DISSECTION, REMOVAL OF PROLIFT MESH, SLING REVISION AND URETHRAL LYSIS, REMOVAL OF MESH FROM THE OBTURATOR INTERNUS MUSCLES, ANTERIOR COLPORRHAPHY, POSTERIOR COLPORRHAPHY,

  Patient problems: Bowel Perforation; Erosion; Injury

  MAUDE report 9241613 ↗
• InjuryOct 11, 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. PER ADDITIONAL INFORMATION RECEIVED, PATIENT HAS EXPERIENCED A SUDDEN INCREASE IN DISCHARGE, ERODED MESH AT THE APEX, DEPRESSION AND REQUIRED ONE SURGICAL INTERVENTION.

  Patient problems: Discharge; Erosion; Injury

  MAUDE report 9180836 ↗
• InjuryOct 2, 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED SEVERE DETRUSOR OVERACTIVITY, URINARY RETENTION, DYSURIA, URINARY TRACT INFECTIONS, STRESS URINARY INCONTINENCE, LOWER URINARY TRACT SYMPTOMS, CLEAN INTERMITTENT CATHETERIZATIONS FOR URINARY RETENTION, URGE URINARY INCONTINENCE, MILD BLADDER TRABECULATIONS, SEVERE BLADDER SPASMS AND INABILITY TO INITIATE VOIDING AFTER BOTOX INJECTION, MILD URETHRAL HYPERMOBILITY, AND REQUIRED MULTIPLE NONSURGICAL INTERVENTIONS AND ONE SURGICAL INTERVENTION.

  Patient problems: Dysuria; Injury; Urinary Retention

  MAUDE report 9144617 ↗
• InjurySep 24, 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 9110813 ↗
• InjurySep 24, 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 9109849 ↗