Align® TO Trans-Obturator Urethral Support System - Hook & Halo BRD600HHRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00801741016233), received between Jan 30, 2012 and Jul 21, 2023 — classified as 61 injuries.

The most frequently reported specific device problem is “Defective Device” (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 61 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 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 17368837 ↗
• InjuryJul 11, 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 17295722 ↗
• InjuryJun 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 INJURY, PAIN, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED HYPERTENSION, ¿SPELLS¿ (FACE AND EYES FEEL PUFFY, TOP OF MOUTH GETS BIG AND DENTURES DON¿T FIT, NECK GETS FLUSHED-PATIENT ATTRIBUTES TO MESH), ¿JITTERS,¿ ¿APPREHENSION,¿ ANXIETY, ¿BURPING AND GAS,¿ DIAGNOSED WITH EMPTY SELLA SYNDROME ((B)(6) 2011), MULTIPLE SYMPTOMS ATTRIBUTED BY PATIENT TO MESH IMPLANT SURGERY ON (B)(6) 2009 (¿EYES WATERING AND SQUINTY; FEELS UNEVEN, WHICH APPEARS TO BE RELATED TO DECREASED BALANCE; TEETH FEEL FOREIGN; LOWER BACK PAIN, CONSTANT PRESSURE IN FACE; BACK OF HEAD HURTS; NECK GETS TIGHT; PATIENT GETS COLD [ESPECIALLY HANDS, WHICH GET COLD, NUMB, AND SPLOTCHY]; STOMACH HURTS; DIZZINESS (VERTIGO); LIGHTHEADEDNESS; FEELING DRAINED AND TIRED; CONSTANT RUNNY NOSE; CHOKING OR GAGGING AT TIMES; STOMACH BLOATED; MUSCLES IN BODY WILL TIGHTEN AND RELEASE; BRUISES EASILY; SOUR TASTE AND BAD BREATH; SWELLING THAT COMES AND GOES; NAUSEA; IF SHE DOES NOT HAVE A BOWEL MOVEMENT WHEN SHE FEELS THE URGE, S

  Patient problems: Abdominal Pain; Anxiety; Arthralgia; Autoimmune Disorder; Blurred Vision; Constipation; Cramp(s) /Muscle Spasm(s); Cyst(s); Depression; Diaphoresis; Dysuria; Erosion; Fibromyositis; Genital Bleeding; Hernia; High Blood Pressure/ Hypertension; Incontinence; Nausea; Nerve Damage; Neuropathy; Numbness; Sore Throat; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Vitamin Deficiency

  MAUDE report 17181216 ↗
• InjuryApr 12, 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, DISCOMFORT, URINARY PROBLEMS, AND DYSPAREUNIA. PATIENT HAS REQUIRED ADDITIONAL SURGICAL INTERVENTIONS. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, EROSION AND URINARY INCONTINENCE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED VIA LITIGATION RECEIVED FEBRUARY 22, 2019, THE PATIENT HAS EXPERIENCED PAIN, DISCOMFORT, URINARY PROBLEMS, DYSPAREUNIA AND ADDITIONAL SURGERIES. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 16MAR2023, THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY, COMFORT, CONSORTIUM, WRONGFUL DEATH DAMAGES, SURVIVORSHIP DAMAGES AND REQUIRED ADDITIONAL NON-SURGICAL TREATMENTS.

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

  MAUDE report 16726236 ↗
• InjurySep 30, 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: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyspareunia; Erosion; Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Hyperplasia; Micturition Urgency; Neuropathy; Pain; Prolapse; Rash; Urinary Incontinence

  MAUDE report 15518946 ↗
• InjuryOct 20, 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, THE PATIENT HAS EXPERIENCED MORBID OBESITY, 80 POUND WEIGHT GAIN OVER ONE YEAR, BILATERAL LEG SWELLING/EDEMA, LEG PAIN (JOINT PAIN), CALF TENDERNESS, MESH NOTED ON SIDE OF URETHRA/PROTRUDING INTO VAGINA (FOREIGN BODY IN PATIENT), CHRONIC PAIN, FREQUENT NIGHT TIME URINATION, AND REQUIRED ADDITIONAL NON SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED ON 16OCT2021, THE PATIENT HAS EXPERIENCED MENTAL ANGUISH, PHYSICAL PAIN, DISFIGUREMENT AND PHYSICAL IMPAIRMENT.

  Patient problems: Foreign Body In Patient; Pain; Swelling/ Edema; Urinary Frequency / Polyuria; Weight Changes

  MAUDE report 12669622 ↗
• 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. AS PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT¿S POST IMPLANTATION SYMPTOMS ARE UNKNOWN DUE TO LIMITED NUMBER OF MEDICAL RECORDS.

  Patient problems: Injury

  MAUDE report 11073831 ↗
• 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 LEFT HIP PAIN, WEAKNESS OF THE LEG, DIZZINESS, WEAKNESS, LIGHTHEADEDNESS, URINARY TRACT INFECTION, MENOPAUSAL AND POSTMENOPAUSAL DISORDER, MALAISE, FATIGUE, MAJOR DEPRESSIVE DISORDER, INSOMNIA, PAINFUL URINATION, FREQUENCY, URGENCY, FEVER, ABDOMINAL PAIN (PELVIC PAIN), HEADACHE, VAGINA ATROPHIC, FEMALE STRESS INCONTINENCE, URGE INCONTINENCE OF URINE, URINARY LEAKAGE, WEIGHT LOSS/GAIN, HIVES, FLU, CHEST PAIN, PAIN AS ARTHRITIS, DEPRESSION, SLEEPING ISSUES, ACUTE CYSTITIS, URINARY INCONTINENCE, INTRINSIC SPHINCTER DEFICIENCY, BLOOD IN THE URINE, ADNEXAL TENDERNESS, VAGINITIS AND VULVOVAGINITIS. THE PATIENT REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Injury; Pain; Weakness

  MAUDE report 11056356 ↗
• 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 ONE EPISODE OF VAGINAL BLEEDING, DYSPAREUNIA, STRESS URINARY INCONTINENCE, DECREASED LIBIDO, BIOPSY OF VAGINAL LESIONS, FIBROEPITHELIAL POLYP, SWELLING TO BILATERAL LOWER EXTREMITIES, TIGHT AND A SENSATION LIKE A "GUITAR STRING" IN VAGINA DURING INTERCOURSE, HUSBAND STATED IT FELT LIKE A CHEESE SLICER AND NO LONGER HAVING INTERCOURSE SECONDARY TO PAIN, URGENCY, URGE INCONTINENCE, URINARY FREQUENCY, NOCTURIA, LEG/GROIN PAIN, FOREIGN BODY IN VULVA AND VAGINA, CHRONIC PAIN IN RIGHT AND LEFT THIGH, GENITAL PROLAPSE, HYPERMOBILE BLADDER NECK, VAGINAL EROSION FROM TRANSVAGINAL TAPE, DYSURIA, VAGINAL PAIN, MESH EXPOSURE, URETHRAL SCARRING, SCAR TISSUE AND CYSTOCELE DISSECTION, INFECTED MESH, AND URINE LEAKAGE. SHE HAS REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9799990 ↗
• 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, AND DISABILITY. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED LOW BACK PAIN, URINARY FREQUENCY, HESITANCY, VAGINAL DISCHARGE, SLOW HEALING, OCCASIONAL STRESS INCONTINENCE, URINARY URGENCY, GRANULATION TISSUE, CONSTIPATION, ACUTE ONSET OF LEFT LEG PAIN, CHRONIC URINARY TRACT INFECTIONS, DRAIN IN THE CUL-DE-SAC DRAINING SEROSANGUINOUS FLUID, INFLAMMATION, SPOTTING, PELVIC PAIN, CYSTITIS, FRANK INCONTINENCE, LIGHT ERYTHEMA OVER LABIA MAJORA AND MINORA ABOUT 1CM UP ONTO THE MONS, FOLEY CATHETER PLACEMENT, INFECTIOUS PROCESS COMING FROM THE PELVIS AND/OR THE BLADDER, SUBCUTANEOUS FLUID OR EDEMA IN PROXIMAL LEFT THIGH MEDIALLY AND SUPRAPUBIC AREA IN THE VULVAR AREA, CELLULITIC RASH ON LOWER ABDOMEN, GROIN AND THIGHS, SEVERE ABDOMINAL PAIN, LEFT GROIN AND VULVAR CELLULITIS, BLEEDING, COMPUTED TOMOGRAPHY GUIDED DRAIN IN PELVIS, LEUKOCYTOSIS, PAIN IN LEFT PROXIMAL THIGH, VULVA, PUBIC SYMPHYSIS AND LEFT INGUINAL AREA, LEFT PROXIMAL THIGH CELLULITIS, PELVIC FLUID COLLECTION CULTURE POSITIVE FOR GROUP A STREPTOCOCCI, POLYMICROBIAL CELLULITIS,

  Patient problems: Diarrhea; Numbness; Tingling

  MAUDE report 9750453 ↗
• InjuryNov 1, 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 URGENCY AND FREQUENCY, LEVATOR AND ANAL SPASMS, URGE INCONTINENCE, BLADDER SPASMS, MIDLINE CYSTOCELE, STRESS INCONTINENCE, RECTOCELE, VAGINAL APICAL PROLAPSE GRADE TWO, ANTERIOR COLPORRHAPHY WITH SACROSPINOUS LIGAMENT FIXATION USING A HUMAN DERMAL GRAFT, VAGINAL MESH EXCISION, TRANSVAGINAL SUBURETHRAL SLING (TVT SLING) BIOLOGIC USING HUMAN FASCIA LATA, DIAGNOSTIC CYSTOSCOPY, AND SMOKING, EGD WITH BIOPSY (X2), ULCERATIVE GASTRITIS AND HIATAL HERNIA, RECURRENT URINARY TRACT INFECTIONS, ABNORMAL LOCATION OF SUBURETHRAL SLING, HYPERMOBILE URETHRA, PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, FISTULAE, RECURRENCE, BLEEDING, NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING, SEVERE DYSPAREUNIA, SUSPECTED INTERSTITIAL CYSTITIS, MULTIPLE HEMORRHAGIC CYSTS AND ULCERS THROUGHOUT THE BLADDER, URETHRAL SCAR, PARAVAGINAL DEFECTS, SEVERE ABDOMINAL PAIN, PELVIC PROLAPSE, SEVERE CHRONIC PELVIC PAIN AND PRESSURE WITH PULLING SENSATION, PALPABLE MESH ON ANTERIOR VAGINAL WALL, BLADDER SPASMS, ACUTE VAGINITIS, DYSURIA, FEVER, URINE RETENTION, PROCTOCELE, HER

  Patient problems: Injury; Micturition Urgency; Urinary Frequency / Polyuria

  MAUDE report 9266126 ↗
• InjuryOct 23, 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; Unspecified Infection

  MAUDE report 9227319 ↗
• 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, THE PATIENT HAS EXPERIENCED INFECTION, URINARY URGENCY, PAIN WITH BOWEL MOVEMENT, DYSURIA, URGENCY WITH URINATION, INCOMPLETE EMPTYING, EXCISION OF SUTURE AT INTROITUS, VAGINAL BLEEDING, RECTOCELE, GRANULATION TISSUE AT VAGINAL CUFF, POSTERIOR PROLAPSE REQUIRING SPLINTING FOR BOWEL MOVEMENTS, SEVERE CONSTIPATION, URINARY TRACT INFECTION, CLOSTRIDIUM DIFFICILE COLITIS INFECTION, PELVIC RELAXATION, MUCOSAL SEPARATION OF POSTERIOR REPAIR, VAGINAL DISCHARGE, PELVIC PAIN, PERINEAL DISCOMFORT, ODOROUS DISCHARGE, VAGINAL INFECTION, SENSATION OF PRESSURE IN BLADDER AREA, ONE SURGICAL INTERVENTION AND MULTIPLE NONSURGICAL INTERVENTIONS.

  Patient problems: Constipation; Intermenstrual Bleeding; Prolapse

  MAUDE report 9180837 ↗
• 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 9161876 ↗
• InjurySep 26, 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 9124108 ↗
• InjurySep 19, 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 9086220 ↗
• InjurySep 18, 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 OBSTRUCTIVE VOIDING SYMPTOMS, HYPERELEVATION OF THE VESICAL NECK, PERIURETHRAL FIBROSIS AND ONE SURGICAL INTERVENTION.

  Patient problems: Fibrosis; Injury; Obstruction/Occlusion

  MAUDE report 9081361 ↗
• InjurySep 18, 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 HYPER ELEVATION OF THE VESICAL NECK, STRESS URINARY INCONTINENCE, MALPOSITIONED TRANSOBTURATOR TAPE SLING, FIBROSIS AND REQUIRED TWO SURGICAL INTERVENTIONS.

  Patient problems: Fibrosis; Incontinence; Injury

  MAUDE report 9081339 ↗
• InjurySep 17, 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 MENORRHAGIA, EXTENSIVE ABDOMINAL ADHESIONS AND REQUIRED ONE SURGICAL INTERVENTION.

  Patient problems: Adhesion(s); Injury

  MAUDE report 9075293 ↗
• InjurySep 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED A SEVERE REFRACTORY OVERACTIVE BLADDER, URGE INCONTINENCE, MILD BLADDER TRABECULATIONS, URINARY RETENTION, URINARY URGENCY AND REQUIRED MULTIPLE SURGICAL AND NONSURGICAL INTERVENTIONS.

  Patient problems: Incontinence; Injury; Urinary Retention

  MAUDE report 8983895 ↗
• InjurySep 5, 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 POSTOPERATIVE BLEEDING REQUIRING EVACUATION OF THE HEMOPERITONEUM AND CAUTERIZATION OF THE UTERINE ARTERIES. SHE HAS REQUIRED ONE SURGICAL INTERVENTION TO DATE.

  Patient problems: Injury; Intermenstrual Bleeding

  MAUDE report 8965185 ↗
• InjuryAug 26, 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 8932156 ↗
• InjuryAug 22, 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 8921323 ↗
• InjuryAug 12, 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 8885188 ↗
• InjuryAug 12, 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 8885084 ↗