Align® TO Trans-Obturator Urethral Support System - Halo BRD500HLRecalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00801741016226), received between Jan 4, 2013 and Oct 25, 2024 — classified as 213 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (12 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 213 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 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 01OCT2024, THE PATIENT HAD EXPERIENCED SYMPTOMATIC CYSTO-URETHOCELE, PELVIC PAIN, VAGINAL BLEEDING, MESH EROSION, EXPOSED VAGINAL MESH AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 20DEC2024, THE PATIENT HAD EXPERIENCED CYSTOURETHROCELE, PELVIC PAIN, VAGINAL BLEEDING, MESH EROSION, URINARY FREQUENCY, URINARY TRACT INFECTIONS WITH A FOUL ODOR AND DISCHARGE, PRESSURE SORES, DEGENERATIVE JOINT DISEASE, LEFT HIP PAIN, PANNICULITIS, HEARTBURN, REFLUX DISEASE, SECOND DEGREE ENTEROCELE, ANEMIA, OBESITY, HYPERTENSION, LEFT ANKLE PAIN, OSTEOARTHRITIS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abnormal Vaginal Discharge; Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Erosion; Heartburn/Indigestion; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Pain; Pressure Sore/Ulcer; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 20531526 ↗
• InjuryJun 13, 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 PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. AS PER MEDICAL RECORD REVIEW OF DOCUMENTS RECEIVED ON 17-MAY-2024, THE PATIENT HAD EXPERIENCED URINARY TRACT INFECTION, ABDOMINAL PAIN, VITAMIN D DEFICIENCY, VITAMIN B12 DEFICIENCY , LOWER GASTROINTESTINAL BLEED SECONDARY TO COLITIS, VAGINAL MESH EXPOSURE, FREQUENCY, URGENCY, OBSTRUCTED URETHRA, DIVERTICULITIS, INCOMPLETE BLADDER EMPTYING, MUSCLE SPASM, VAGINAL BLEEDING, URGE INCONTINENCE, THICKENED CERVIX, CYSTOCELE, UTERINE PROLAPSE, EXPOSURE OF OTHER PROSTHETIC MATERIALS INTO ORGAN OR TISSUE, OVERACTIVE BLADDER, SORES, HEARTBURN AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Cramp(s) /Muscle Spasm(s); Genital Bleeding; Hemorrhage/Blood Loss/Bleeding; Incontinence; Inflammation; Micturition Urgency; Obstruction/Occlusion; Prolapse; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 19526837 ↗
• 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 INJURY, SEVERE AND PERMANENT PAIN, SUFFERING, DISABILITY, IMPAIRMENT. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 01DEC2023 THE PATIENT HAD EXPERIENCED STRESS URINARY INCONTINENCE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

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

  MAUDE report 18387349 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DURING SURGERY PROLAPSED BLADDER SLING. PATIENT WAS COMPLETELY UNAWARE THAT THEY HAD ANY TYPE OF SLING OTHER THAN THE FIRST ONE THEY HAD EVER HAD, WHICH WAS FROM THE THIGH OF THE CADAVER USING THE MUSCLE OF A CADAVER THIS SURGERY WAS IN 2013 IN SURGERY CENTER. PATIENT DID NOT KNOW THEY HAD A MESH SLING INSIDE OF THEM UNTIL THEY SAW THE UROLOGIST IN 2019. IN 2013, PATIENT SAW DOCTOR AS THEY WERE EXPERIENCED STOMACH ISSUES, HORRIFIC PAINS, AND UNEXPLAINED PAIN IN THEIR RIGHT LOWER BACK. PATIENT HAD NOT HURT THEMSELVES, ANYTHING. PATIENT HAD TERRIBLE UNEXPLAINED GAGGING AT TIMES, VOMITING IF THEY EVEN TOOK A DRINK OF WATER, CHOKING, AND WOULD HAVE TO RUN TO THE SINK WHEN THEY LAID DOWN. AFTER A FEW TESTS, DOCTOR INFORMED PATIENT THAT THEIR GALLBLADDER HAD RUPTURED. DOCTOR ASKED PATIENT IF THEY HAD ANY SIGNS, AND PATIENT EXPLAINED THE CHOKING, VOMITING, AND OTHER THINGS. THE START OF MANY ILLNESSES, HOSPITAL VISITS, AND THEIR BODY SLOWLY DETERIORATING OVER THESE PAST YEARS. FINDING THE MESH ON 2019 WAS THE LAST PUZZLE PIECE. PATIENT NEVER FELT THE SAME AFTER RECOVERING FROM THE SECOND SLING FOR THEIR PROLAPSED BLADDER. APPROXIMATELY SIX MONTHS LATER, PATIEN

  Patient problems: Abdominal Distention; Abnormal Vaginal Discharge; Ambulation or Postural Difficulties; Anxiety; Bacterial Infection; Burning Sensation; Choking; Cognitive Changes; Confusion/ Disorientation; Cramp(s) /Muscle Spasm(s); Diarrhea; Discomfort; Emotional Changes; Erosion; Fatigue; Fungal Infection; Headache; Inflammation; Localized Skin Lesion; Pain; Rupture; Skin Inflammation/ Irritation; Sleep Dysfunction; Unspecified Immune System Problem; Vomiting

  MAUDE report 17631893 ↗
• 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 17295721 ↗
• InjuryMay 5, 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 11APR2022, THE PATIENT HAS EXPERIENCED EXTREME PAIN, EMOTIONAL PAIN, YEAST INFECTION, URINARY RETENTION, URINARY INCONTINENCE, PELVIC PAIN, PRESSURE NUMBNESS, BURNING IN VAGINA AND VULVA, INVOLUNTARY LOSS OF URINE, EROSION OF SLING, DISCOMFORT, DYSPAREUNIA, VAGINAL PAIN AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Constipation; Discomfort; Erosion; Incontinence; Numbness; Urinary Frequency / Polyuria; Urinary Retention

  MAUDE report 14286544 ↗
• InjuryMar 1, 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 CLAIM RECORD ON (B)(6) 2022, THE PATIENT HAS EXPERIENCED A RECURRENT URINARY TRACT INFECTION, HEMATURIA, BLEEDING, EROSION OF THE VAGINAL MESH, MENTAL AND PHYSICAL PAIN, DISABILITY, SUFFERING, PERMANENT INJURIES, SUBSTANTIAL PHYSICAL DEFORMITY, SEVERE EMOTIONAL DISTRESS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Apnea; Asthma; Cancer; Cramp(s) /Muscle Spasm(s); Distress; Erosion; Fatigue; Hematuria; Hemorrhage/Blood Loss/Bleeding; Hernia; High Blood Pressure/ Hypertension; Incontinence; Low Blood Pressure/ Hypotension; Nausea; Pain; Prolapse; Unspecified Infection; Urinary Retention; Urinary Tract Infection

  MAUDE report 13636436 ↗
• 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.

  Patient problems: Unspecified Infection

  MAUDE report 12916643 ↗
• InjuryDec 2, 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 PATIENT HAS EXPERIENCED INJURY, PAIN, DISCOMFORT, URINARY PROBLEMS, DYSPAREUNIA AND MULTIPLE CORRECTIVE SURGERIES. PER ADDITIONAL INFORMATION RECEIVED ON 12NOV2021, THE PATIENT HAS EXPERIENCED VAGINAL PAIN, MESH EROSION, DYSURIA, MESH TIGHTNESS ALONG THE RIGHT VAGINAL WALL, LEFT KNEE PAIN, HYPERLIPIDEMIA, BENIGN ESSENTIAL HYPERTENSION, CORONARY ARTERIOSCLEROSIS IN NATIVE ARTERY, NECK PAIN, THORACIC BACK PAIN, CHRONIC BACK PAIN, STIFFNESS, DISCOMFORT AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Arteriosclerosis/ Atherosclerosis; Discomfort; Dysuria; Erosion; High Blood Pressure/ Hypertension; Neck Pain; Neck Stiffness; Pain

  MAUDE report 12915225 ↗
• InjuryNov 15, 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 ON 01NOV2021, THE PATIENT HAS EXPERIENCED RASH ON BODY, HIDRADENITIS, ANXIETY WITH DEPRESSION, SEVERE UPPER STOMACH PAIN, CYSTIC LESIONS ON THE CERVIX, DENTAL ABSCESS, RIB PAIN ON THE LEFT SIDE, POST TRAUMATIC STRESS DISORDER, PAIN DURING COUGHING AND SNEEZING, INSOMNIA, CERVICAL SMEAR, SUICIDAL INTENT, MILD DYSKARYOSIS, LACERATION IN LEFT THIGH, OVERDOSE OF DRUGS, EPIGASTRIC PAIN, VAGINAL BLEEDING, PAIN DURING SEXUAL INTERCOURSE, CHEST PAIN, ABDOMINAL PAIN, MULTIPLE CALCULI IN GALL BLADDER, PAIN IN RIGHT UPPER QUADRANT, GALL STONES, DYSPAREUNIA LEADING TO APAREUNIA, PERSISTENT STITCH MIDLINE, IRREGULAR BLEEDING, VAGINAL DISCHARGE, PERSISTENT STRESS URINARY INCONTINENCE, MESH EROSION IN THE MIDLINE JUST UNDER THE URETHRA, NECK PAIN, SEVERE HEADACHE, BREAST LUMP IN THE RIGHT AXILLAE, INFLAMMATION, SWELLING, LUMP IN ARMPITS, PAIN IN VAGINA, MUSCLE SPASM, CERVIX WITH BULKY LIKE APPEARANCE AND INFLAMED, URGE INCONTINENCE, URINARY LEAKAGE, URINARY URGENCY, DYSURIA, CLOUDY URINE, URINARY TRACT INFECTION AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Abscess; Anxiety; Breast Mass; Chest Pain; Cramp(s) /Muscle Spasm(s); Cyst(s); Depression; Dyspareunia; Dysuria; Erosion; Headache; Inflammation; Intermenstrual Bleeding; Micturition Urgency; Neck Pain; Pain; Rash; Swelling/ Edema; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 12811162 ↗
• InjuryOct 29, 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 12721437 ↗
• InjuryOct 29, 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 15OCT2021, THE PATIENT HAS EXPERIENCED LEFT SIDED VAGINAL PAIN, BLADDER LEAKAGE, URINARY URGENCY, SEVERE DYSPAREUNIA, CHRONIC FATIGUE SYNDROME, HYPERTONICITY OF BLADDER, BLADDER SPASM, CHRONIC PAIN, NECK PAIN, BACK PAIN, BLEEDING, ANEMIA, HYPOKALEMIA, HYPOMAGNESEMIA, LOW GRADE FEVER, RECURRENT STRESS INCONTINENCE, URINARY LEAKAGE, PAIN DURING SEXUAL INTERCOURSE, STABBING PAIN IN BLADDER, SPOTTING, ABNORMAL GRANULATION TISSUE, OVARIAN CYST, TENDERNESS, PELVIC ADHESIONS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Adhesion(s); Anemia; Cyst(s); Dyspareunia; Fatigue; Fever; Intermenstrual Bleeding; Micturition Urgency; Neck Pain; Pain; Urinary Incontinence

  MAUDE report 12721353 ↗
• InjuryOct 28, 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 12710782 ↗
• 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. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 15OCT2021, THE PATIENT HAS EXPERIENCED STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE, CYSTOCELE, RECTOCELE, VAGINAL PAIN, DRYNESS, PELVIC PAIN, MESH EROSION, DYSPAREUNIA, EXTRUSION, ABDOMINAL CRAMPS, BLOODY VAGINAL DISCHARGE, URINARY LEAKAGE, MIXED INCONTINENCE, NOCTURIA, ENURESIS, INCOMPLETE EMPTYING OF BLADDER, ANXIETY, HYPERTENSION, HYPERCHOLESTEROLEMIA, ACUTE VAGINITIS, ADHESIONS, METROMENORRHAGIA, UTERINE FIBROIDS, MENSTRUAL BLEEDING, DYSMENORRHEA, VAGINAL SPOTTING, ACUTE APPENDICITIS, ABDOMINAL PAIN, NAUSEA, DISCOMFORT, LOSS OF APPETITE, DIARRHEA AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Cramps; Abdominal Pain; Abnormal Vaginal Discharge; Adhesion(s); Anxiety; Diarrhea; Discomfort; Dyspareunia; Erosion; High Blood Pressure/ Hypertension; Intermenstrual Bleeding; Nausea; Pain; Prolapse; Urinary Incontinence

  MAUDE report 12703525 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE PATIENT'S PLAINTIFF FACT SHEET, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISCOMFORT AND EXTREME DRYNESS DURING SEXUAL INTERCOURSE, CONSTANT UTI'S AND DEPRESSION. PER ADDITIONAL INFORMATION RECEIVED ON 11OCT2021, THE PATIENT HAS EXPERIENCED PAIN, DISCOMFORT, EXTREME DRYNESS DURING SEXUAL INTERCOURSE, URINARY TRACT INFECTIONS, DEPRESSION, DYSPAREUNIA, MESH BROKEN INSIDE THE PATIENT, ENTEROCELE, SEVERE CRAMPS, CYSTOCELE, HERNIA, FIBROIDS, RECTOCELE, BLADDER INFECTIONS, VAGINAL VAULT PROLAPSE, UTERINE PROLAPSE, URINARY INCONTINENCE, URINARY RETENTION, RECURRENT VAGINAL PAIN, MESH EXPOSURE IN VAGINA, URINARY FREQUENCY, URINARY LEAKAGE, URGE INCONTINENCE, NOCTURIA, URINARY URGENCY, LOWER BACK PAIN, ENDOCERVICAL POLYPS, MINIMAL URETHRAL HYPERMOBILITY, OVARIAN CYST, MILD PELVIC TENDERNESS, HEMATURIA, ABDOMINAL DISTENTION, OSTEOPOROSIS, GASTROESOPHAGEAL REFLUX DISEASE, LOW BONE DENSITY, ENLARGED LIVER, NODULE IN THE SUPERIOR ASPECT OF THE RIGHT BREAST, CHRONIC INFLAMMATION, FOREIGN BODY GIANT CELL REACTION AND FIBROSIS AND BENIGN SQUAMOUS MUCOSA, DIZZINESS, BLURRED VISION AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTE

  Patient problems: Abdominal Distention; Blurred Vision; Cramp(s) /Muscle Spasm(s); Cyst(s); Depression; Discomfort; Dizziness; Dyspareunia; Fibrosis; Hematuria; Hernia; Inflammation; Micturition Urgency; Osteopenia/ Osteoporosis; Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 12688561 ↗
• 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 INJURY, PAIN, DISCOMFORT, DISABILITY AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, THE PATIENT HAS EXPERIENCED MESH EROSION, DYSPAREUNIA, VAGINAL DISCHARGE, FOUL ODOR, SEVERE PELVIC PAIN, ABDOMINAL PAIN, VAGINAL INFECTION, FREQUENT URINARY TRACT INFECTIONS, VAGINAL IRRITATION, CYSTOCELE, PELVIC TUMORS OR FIBROIDS, PAIN DURING SEXUAL INTERCOURSE, VAGINAL PAIN AND PRESSURE, URINARY INCONTINENCE, URINARY RETENTION, UTERINE PROLAPSE, VAGINAL VAULT PROLAPSE, WOUND HEALING PROBLEMS, CONSTIPATION AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Constipation; Dyspareunia; Erosion; Fibrosis; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Pain; Prolapse; Skin Inflammation/ Irritation; Urinary Incontinence; Urinary Retention; Urinary Tract Infection; Vaginal Mucosa Damage

  MAUDE report 12302998 ↗
• InjuryAug 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. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MALAISE, FATIGUE, ULCERATION OF VULVA (ULCERATION), UNSPECIFIED ABNORMAL FINDINGS IN URINE, BACTERIA IN URINE (BACTERIAL INFECTION), URINARY TRACT INFECTION (UTI), CANDIDIASIS VULVA/VAGINA (FUNGAL INFECTION), DYSURIA, HERPES SIMPLEX VIRUS, AND REQUIRED ADDITIONAL NON-SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, AND DYSPAREUNIA. PER ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 18, 2018, THE PATIENT HAS EXPERIENCED PAIN, UNSPECIFIED URINARY PROBLEMS, RETENTION, CONSTIPATION, BLADDER INFECTIONS, VAGINAL SCARRING (SCAR TISSUE), PAINFUL INTERCOURSE, DEPRESSION, ACHING, LOW ENERGY, DYSPAREUNIA, CHRONIC PAIN REGIONAL SYNDROME, VAGINAL/BLADDER INFECTIONS, VAGINAL PAIN, URINARY RETENTION, DEPRESSION, DIFFICULTY WITH INTIMACY AND NONSURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED ON OCTOBER 16, 2018, THE PATIENT HAS EXPERIENCED SLOWING OF FORCE OF URINE STR

  Patient problems: Abdominal Pain; Bacterial Infection; Bronchitis; Chills; Constipation; Cyst(s); Depression; Dyspareunia; Dysuria; Fatigue; Fungal Infection; Headache; Hematuria; Malaise; Micturition Urgency; Myalgia; Neuropathy; Pain; Paresis; Scar Tissue; Sore Throat; Ulcer; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 12272082 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DURING SEXUAL INTERCOURSE. IT WAS ALSO REPORTED THAT THE PATIENT HAD PAIN IN THE GROIN, HIPS, THIGHS, KNEES DURING MOBILIZATION AND HAD PAIN DURING SLEEP.

  Patient problems: Pain

  MAUDE report 12188970 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD VAGINAL PAIN DURING AND AFTER INTERCOURSE AND AS A SENSATION OF AN ELASTIC THAT CONSTANTLY PULLS IN THE VAGINAL PARTIES UP TO THE BELLY AND LEG. IT WAS ALSO REPORTED THAT THE PATIENT HAD PELVIC PAIN, PAIN IN THE BUTTOCKS AND THE THIGHS LEGS.

  Patient problems: Pain

  MAUDE report 12188860 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STOMACH ACHE AND GROIN PAIN.

  Patient problems: Pain

  MAUDE report 12188850 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED PAIN IN THE HIPS, LOWER BACK, DIFFICULTY IN STANDING LONG AND PRESSURE IN THE VAGINA WITH BURNING SENSATION. THE PATIENT ALSO EXPERIENCED SPONTANEOUS ALLERGIC REACTIONS LIKE ITCHY SKIN AND REDNESS.

  Patient problems: Itching Sensation; Pain

  MAUDE report 12188824 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ALLEGED PAIN IN THE UPPER PART OF THE PELVIS AND RIGHT LEG AND LOWER ABDOMEN.

  Patient problems: Pain

  MAUDE report 12188658 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED PAIN IN THE GROINS AND CONSTANT BURNING IN THE BACK THIGHS AND BUTTOCKS. ALSO EXPERIENCED BEGINNING OF HIP PAIN AND PAIN IN THE PUBIC SYMPHYSIS.

  Patient problems: Pain

  MAUDE report 12188643 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD VAGINAL SAGGING AND BLADDER DESCENT. THE PATIENT HAD OPERATION WENT WELL, BUT WAS VERY PAINFUL AND STRESS INCONTINENCE WAS RESOLVED. ON THE OTHER HAND, A VERY DEEP PAIN IN THE HIP AND LEFT BUTTOCK CAME BACK AND IT WENT DOWN INTO THE THIGH TO THE KNEE. PATIENT LEG HAD LOST SOME STRENGTH AND IT DID NOT LIFT LIKE THE OTHER AS IF IT WAS HEAVIER. THE PATIENT ALSO HAD A LITTLE BIT OF PAIN ON THE OTHER HIP, BUT A LOT LESS PAIN. ALSO THE PATIENT BLADDER STARTED ACTING UP AGAIN AND HAD FREQUENT URINARY EMERGENCIES AND FELT PRESSURE IN THE VAGINA AT LEAST TWICE A DAY.

  Patient problems: Pain

  MAUDE report 12188473 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CONSTANT DISCOMFORT AND CONTINUAL URINARY TRACT INFECTIONS WHICH WAS TREATED WITH ANTIBIOTICS AT LEAST ONCE EVERY THREE MONTHS. IT WAS ALSO STATED THAT THERE WAS A NEUROLOGICAL OCCURRENCE AND A POSSIBILITY THAT THE TOXINS HAD CREATED FROM IMPLANT.

  Patient problems: Discomfort; Urinary Tract Infection

  MAUDE report 12188468 ↗