Restorelle 501420Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05708932483834), received between Jul 13, 2021 and Jan 22, 2026 — classified as 36 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Device Appears to Trigger Rejection

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD A RESTORELLE Y IMPLANTED IN (B)(6) 2021. REPORTEDLY THE PATIENT EXPERIENCED VAGINAL BLEEDING, PASSING OF LARGE CLOTS AND WAS ADMITTED TO HOSPITAL. CT ABDOMEN/PELVIS ¿ WAS PERFORMED AND IDENTIFIED A SMALL AMOUNT OF COMPLEX FLUID IN VAGINAL VAULT LIKELY REPRESENTING BLOOD PRODUCTS, OTHERWISE NORMAL. ON EXAM ERODED AREA AT VAGINAL APEX IN WHICH MESH IS EXPOSED, AREA BLEEDS EASILY WHEN TOUCHED. OUTPATIENT EXCISION OF EXTRUDED MESH PROPOSED. NO CONFIRMATION OF EXCISION BEING PERFORMED AT THIS TIME.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Adhesion(s); Deformity/ Disfigurement; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Intermenstrual Bleeding; Pain; Pelvic Pain; Prolapse; Scar Tissue; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 24153092 ↗
• InjuryJan 5, 2026Malposition of Device

  AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT ALSO EXPERIENCED URINARY URGENCY/FREQUENCY, NOCTURIA, FEELING OF INCOMPLETE BLADDER EMPTYING, RANDOM BLOOD IN TOILET AFTER SEX, DYSURIA AFTER SEX, URINARY TRACT INFECTIONS RESISTANT TO ANTIBIOTICS, DYSPAREUNIA, PERSISTENT URETHRAL BURNING (WORSE IN AM THEN IMPROVES), RECURRENT STRESS URINARY INCONTINENCE WITH FULL BLADDER, LEFT HIP PAIN AND MUSCLE SPASM/ HIGH-TONE PELVIC FLOOR DYSFUNCTION.

  Patient problems: Cramp(s) /Muscle Spasm(s); Dyspareunia; Dysuria; Erosion; Hematuria; Intermenstrual Bleeding; Micturition Urgency; Pain; Pelvic Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 23960021 ↗
• MalfunctionNov 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, THE CUSTOMER DISCOVERED A [MESH] TEAR UPON OPENING THE PACKAGE. THE PRODUCT WAS NOT USED IN THE PATIENT. A NEW PRODUCT WAS OPENED AND SUCCESSFULLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526825 ↗
• InjurySep 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT ADDITIONALLY EXPERIENCED URINARY URGENCY, FREQUENCY, URINARY TRACT INFECTION, PELVIC DISCOMFORT WITH A PULLING SENSATION, BILATERAL LOW BACK PAIN WITHOUT SCIATICA. LEG SWELLING, PELVIC PAIN, LOWER BACK PAIN W/ PAIN DOWN BILATERAL LEGS, DULL SENSATION IN VAGINAL WALL. DYSPAREUNIA, CRAMPING, VAGINAL ODOR AND DISCHARGE, STRESS URINARY INCONTINENCE, BURNING/INTENSE MUSCLE SPASMS/CONTRACTIONS, UNABLE TO WALK. MOSTLY ON BED REST, DYSURIA, CONSTIPATION, DIARRHEA, AND REMOVAL OF MESH FROM OBTURATOR AND ADDUCTOR MUSCLE.

  Patient problems: Abnormal Vaginal Discharge; Abnormal scarring; Ambulation or Postural Difficulties; Atrophy; Burning Sensation; Constipation; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Diarrhea; Discomfort; Dyspareunia; Dysuria; Erosion; Inflammation; Pain; Pelvic Pain; Prolapse; Swelling/ Edema; Tactile Disorders; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 23142800 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WAS IMPLANTED WITH A RESTORELLE ON OR ABOUT (B)(6) 2015. THE PATIENT EXPERIENCED FOREIGN BODY REACTION, MESH PROTRUSION, MESH EROSION, PELVIC PAIN, BOWEL PROBLEMS, URINARY PROBLEMS, MENTAL AND PHYSICAL PAIN AND SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, PERMANENT INJURY AND OTHER INJURIES. ON (B)(6) 2024, PATIENT UNDERWENT SURGERY TO REMOVE A PORTION OF THE MESH THAT HAD ERODED INTO PATIENT'S BLADDER.

  Patient problems: Abnormal Vaginal Discharge; Emotional Changes; Erosion; Fistula; Foreign Body Reaction; Hematuria; Micturition Urgency; Pain; Pelvic Pain; Prolapse; Urinary Incontinence; Urinary Retention

  MAUDE report 23015247 ↗
• MalfunctionJul 30, 2025Material Disintegration; Material Disintegration

  ACCORDING TO THE AVAILABLE INFORMATION DURING PLACEMENT OF A RESTORELLE, THE DEVICE REPORTEDLY ¿DISINTEGRATED¿. THE RESTORELLE WAS PLACED ANTERIOR AND POSTERIOR AS USUAL AND SUTURED IN PLACE WITH RUNNING BARBED SUTURE. SURGEON PLACED SACRAL SUTURES AND NOTICED THAT IN THE MIDDLE OF THE SACRAL TAIL, THE INTEGRITY OF THE MESH SEEMED TO BE COMPROMISED AS THE MESH ON THE SACRAL TAIL APPEARED TO DISINTEGRATE. THE MESH WAS EXPLANTED, AND A SECOND MESH WAS PLACED WITH NO TROUBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666597 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT REPORTEDLY HAD A RESTORELLE (L) SLING IMPLANTED IN (B)(6) 2019 AND AN ALTIS MESH IMPLANTED ON AN UNKNOWN DATE. REPORTEDLY THE PATIENT HAD RECURRENT CYSTOCELE REQUIRING COLPORRHAPHY UNDER GENERAL ANESTHESIA, RECURRENT VAGINAL WALL PROLAPSE, CHRONIC PELVIC PAIN, DYSPAREUNIA AND HEMATURIA. THE RESTORELLE SLING WAS EXPLANTED IN (B)(6) 2020. IN (B)(6) 2022 MESH WAS IDENTIFIED NEAR THE VAGINA. ROBOTIC SACROCOLPOPEXY WITH RESTORELLE Y, MESH EXCISION [ALTIS] AND CYSTOSCOPY UNDER GENERAL ANESTHESIA WAS PERFORMED. THE PATIENT REPORTEDLY EXPERIENCED STRESS URINARY INCONTINENCE IN 2022.

  Patient problems: Urinary Incontinence

  MAUDE report 21655147 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, THE PATIENT HAD A RESTORELLEY IMPLANTED AND REPORTEDLY EXPERIENCED THE FOLLOWING: DYSPAREUNIA, POSTCOITAL BLEEDING AND MESH EXPOSURE/ EROSION. THE DEVICE WAS EXPLANTED.

  Patient problems: Dyspareunia; Erosion; Intermenstrual Bleeding; Prolapse

  MAUDE report 21448259 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED MESH EROSION AND EXPOSED MESH, VAGINAL BLEEDING, LOWER ABDOMINAL AND BACK PAIN, DARK BROWN DISCHARGE, CRAMPING, COLOVAGINAL FISTULA, INFLAMMATORY CHANGES, ERYTHEMA IN THE AREA, TENDERNESS TO TOUCH, DYSPAREUNIA, URINARY TRACT INFECTION, HEMATURIA, INCOMPLETE BLADDER EMPTYING, FECAL LEAKAGE AND URINE CULTURE POSITIVE FOR E.COLI. THE MESH WAS FIRMLY EMBEDDED AND NOT ABLE TO BE REMOVED MANUALLY, MESH WAS ULTIMATELY SURGICALLY REMOVED. INTRAOPERATIVE FINDINGS NOTED NO FISTULA PRESENT, AND MESH WAS COMPLETELY FREE OF ALL BOWEL.

  Patient problems: Abdominal Cramps; Abnormal Vaginal Discharge; Bacterial Infection; Dyspareunia; Dysuria; Erosion; Erythema; Fecal Incontinence; Fistula; Hematuria; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Pelvic Pain; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 21267751 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT ALSO EXPERIENCED RECURRENT STRESS URINARY INCONTINENCE AND SCARRING.

  Patient problems: Abnormal Vaginal Discharge; Abnormal scarring; Constipation; Dyspareunia; Dysuria; Erosion; Fever; Hematuria; Inflammation; Intermenstrual Bleeding; Interstitial Cystitis; Micturition Urgency; Nausea; Pain; Sepsis; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 20658802 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THE DEVICE ALSO EXPERIENCED VAGINAL PAIN AND BLEEDING FOR THE LAST 6-8 WEEKS. NORMAL EXAM EXCEPT PROTRUDING MESH ON THE RIGHT UPPER CORNER OF THE VAGINAL APEX. PVR 150 CC. MESH REVISION SURGERY SCHEDULED FOR NEXT YEAR. ALSO REPORTED BUT LIKELY NOT RESTORELLE RELATED, LAPAROSCOPIC-ASSISTED SIGMOID RESECTION WITH CECORECTAL ANASTOMOSIS (CRA) AND VAGINAL REPAIR SECONDARY TO DIVERTICULITIS WITH INTRAOPERATIVE CONSULTATION FOR A VESICOVAGINAL FISTULA ¿ UNKNOWN ANESTHESIA. A SMALL FISTULOUS AREA ON THE RIGHT LATERAL CUFF EDGE WAS IDENTIFIED AND OVERSEWN ROBOTICALLY. GRANULATION AND PERSISTENT VAGINA LESION/TISSUE IN THE VAGINAL CUFF CO2 FULGURATION OF GRANULATION TISSUE WITH AMNIOFIX APPLICATION AND CLOSURE OF THE DEFECT IN THE VAGINAL CUFF ¿ GENERAL ANESTHESIA.

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection; Discomfort; Dyspareunia; Dysuria; Erosion; Fever; Genital Bleeding; Granuloma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Prolapse; Unspecified Infection; Urinary Frequency / Polyuria

  MAUDE report 20547550 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD RESTROLLE MESH IMPLANTED IN (B)(6) 2017. FROM (B)(6) 2017, THE PATIENT EXPERIENCED PALPABLE GORE-TEX SUTURES HOLDING THE MESH IN PLACE, PRESSURE AND CRAMPING, VAGINAL DISCHARGE, STAGE 2 CERVICAL PROLAPSE, VAGINAL BLEEDING, SUPERFICIAL ABRASIONS ON INFERIOR MUCOSAL SURFACE, EROSION OF THE POSTERIOR WALL OF THE VAGINA SECONDARY TO SUTURE TO AFFIX MESH, CLIPPING AND REMOVAL OF EXPOSED SUTURES, VAGINAL MESH EXPOSURE, PELVIC PAIN, VAGINAL DRYNESS AND ITCHING, URINARY URGENCY AND DIFFICULTY STARTING URINARY STREAM. PATIENT ATTENDED EMERGENCY DEPARTMENT IN (B)(6) 2023 WITH GRADE 3 CERVICAL PROLAPSE WITH SIGNIFICANT PAIN. THE PATIENT REPORTEDLY ALSO EXPERIENCED EPISODES OF ACUTE RETENTION, STRESS URINARY INCONTINENCE, DYSPAREUNIA AND PARTNER COMPLAINING OF FEELING SOMETHING SHARP DURING INTERCOURSE. THE MESH WAS EXCISED IN (B)(6) 2023. LYSIS OF ADHESIONS, POSTERIOR REPAIR, VAGINAL MUCOSA TRIMMING, RECTAL EXAMINATION AND CYSTOSCOPY WERE PERFORMED. A NEW RESTORELLE WAS IMPLANTED WITH GORE-TEX SUTURES TO ATTACH IT TO THE EXISTING/ PREVIOUSLY IMPLANTED RESTORELLE. FROM (B)(6) 2023, THERE IS SOME ONGOING TENDERNESS WITH PALPATION OF

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain; Urinary Incontinence; Urinary Retention

  MAUDE report 20533029 ↗
• InjuryOct 25, 2024Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD RESTROLLE MESH IMPLANTED IN (B)(6) 2017. FROM (B)(6) 2017, THE PATIENT EXPERIENCED PALPABLE GORE-TEX SUTURES HOLDING THE MESH IN PLACE, PRESSURE AND CRAMPING, VAGINAL DISCHARGE, STAGE 2 CERVICAL PROLAPSE, VAGINAL BLEEDING, SUPERFICIAL ABRASIONS ON INFERIOR MUCOSAL SURFACE, EROSION OF THE POSTERIOR WALL OF THE VAGINA SECONDARY TO SUTURE TO AFFIX MESH, CLIPPING AND REMOVAL OF EXPOSED SUTURES, VAGINAL MESH EXPOSURE, PELVIC PAIN, VAGINAL DRYNESS AND ITCHING, URINARY URGENCY AND DIFFICULTY STARTING URINARY STREAM. PATIENT ATTENDED EMERGENCY DEPARTMENT IN (B)(6) 2023 WITH GRADE 3 CERVICAL PROLAPSE WITH SIGNIFICANT PAIN. THE PATIENT REPORTEDLY ALSO EXPERIENCED EPISODES OF ACUTE RETENTION, STRESS URINARY INCONTINENCE, DYSPAREUNIA AND PARTNER COMPLAINING OF FEELING SOMETHING SHARP DURING INTERCOURSE. THE MESH WAS EXCISED IN (B)(6) 2023. LYSIS OF ADHESIONS, POSTERIOR REPAIR, VAGINAL MUCOSA TRIMMING, RECTAL EXAMINATION AND CYSTOSCOPY WERE PERFORMED. A NEW RESTORELLE WAS IMPLANTED WITH GORE-TEX SUTURES TO ATTACH IT TO THE EXISTING/ PREVIOUSLY IMPLANTED RESTORELLE. FROM (B)(6) 2023, THERE IS SOME ONGOING TENDERNESS WITH PALPATION OF

  Patient problems: Abnormal Vaginal Discharge; Abrasion; Adhesion(s); Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Micturition Urgency; Pain; Pelvic Pain; Prolapse; Scar Tissue; Sexual Dysfunction; Urinary Incontinence; Urinary Retention; Vaginal Dryness

  MAUDE report 20532858 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED FEVER, GENERAL MALAISE, HOSPITAL STAY FOR PERINEAL PAIN, UTI, MILD PELVIC DISCOMFORT, STRAINING TO VOID, URGENCY, DISCOMFORT, URGE INCONTINENCE, NOCTURNAL ENURESIS, CLAIMANT PASSED SOME TYPE OF ¿CLUMP¿ OF POSSIBLY MESH, BACTERIAL VAGINOSIS IN URINE SAMPLE, LOWER URINARY TRACT INFECTIOUS DISEASE, MIDLINE CYSTOCELE, MIXED URINARY INCONTINENCE, MESH EXPOSURE, MESH EROSION AND EXCISION OF RESTORELLE MESH ON TWO OCCASIONS (2022 AND 2023).

  Patient problems: Discomfort; Erosion; Fever; Micturition Urgency; Pain; Unspecified Infection; Urinary Retention; Urinary Tract Infection

  MAUDE report 20407082 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD RESTORELLE POLYPROPYLENE MESH IMPLANTED IN 2016. REPORTEDLY, FROM 2021 THE PATIENT HAS EXPERIENCED POSTCOITAL BLEEDING, CERVICAL EROSION, INFLAMMATION, VAGINAL LESIONS, VAGINAL DISCHARGE, GRADE 1 RECURRENT RECTOCELE, VAGINAL PAIN, VAGINAL BLEEDING IN ABSENCE OF INTERCOURSE AND INABILITY TO HAVE INTERCOURSE WHICH RESULTED IN EXAMINATION UNDER ANESTHESIA IN (B)(6) 2023. INTRAOPERATIVE FINDINGS INCLUDED NO EVIDENCE OF MESH OR GORE-TEX SUTURES AND APPROXIMATELY 4 CM FRIABLE/GLANDULAR VAGINAL TISSUE EXTENDING FROM CERVIX. PATHOLOGY RESULTS IDENTIFIED NECRO INFLAMMATORY DEBRIS, GRANULATION TISSUE, MARKED ACUTE AND CHRONIC INFLAMMATION, COLONIES OF FILAMENTOUS BACTERIA. VAGINAL BLEEDING REPORTEDLY CONTINUED AND FURTHER EXAMINATION UNDER ANESTHESIA WAS PERFORMED. BENIGN FRAGMENTS OF STROMAL TISSUE WITH INFLAMED GRANULATION CONSISTENT WITH ULCERATION WERE NOTED AND THE MESH WAS ULTIMATELY EXCISED IN (B)(6) 2023. DURING EXCISION, ADHESIONS OF SIGMOID COLON AND RECTOSIGMOID INTO THE PELVIS WERE NOTED IN ADDITION TO A RESOLVING HEMATOMA. IN 2024 THE PATIENT REPORTEDLY EXPERIENCED POSTSURGICAL NEUROPATHY AND HAD GRADE 3 RECURRENT RE

  Patient problems: Abnormal Vaginal Discharge; Dyspareunia; Erosion; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Neuropathy; Pain; Prolapse; Sexual Dysfunction; Unspecified Infection

  MAUDE report 20097136 ↗
• MalfunctionJun 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN PLACING THE RESTORELLE MESH, A TEAR/ HOLE WAS NOTED IN THE MESH. AFTER PLACING A SUTURE, THE PHYSICIAN CONTACTED THE MANUFACTURER'S REPRESENTATIVE TO DISCUSS THE TEAR. ULTIMATELY, IT WAS DECIDED TO REMOVE THE SUTURE AND MESH. A SECOND MESH WAS SUCCESSFULLY PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519745 ↗
• InjuryApr 5, 2024Stretched; Material Split, Cut or Torn; Stretched; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION RECEIVED ON 3/13/2024, THE PATENT WAS OPERATED ON IN 2020. A RESTORELLE WAS IMPLANTED. THE PATIENT CAME BACK IN (B)(6) 2023 WITH RECURRENT PROLAPSE AND A RECENT DIAGNOSIS OF CONNECTIVE TISSUE DISORDER. THE PATIENT RETURNED FOR SURGERY DURING WHICH IT WAS OBSERVED THAT THE MESH HAD A VERY SKINNY TAIL BUT WAS STILL ATTACHED TO THE SACRUM AND WAS STILL ATTACHED VAGINALLY. IT APPEARED TO HAVE STRETCHED OUT A LOT, OR HAD TORN; THEREFORE, THE DECISION WAS MADE TO REMOVE THE RESTORELLE AND ANOTHER COMPANY¿S MESH WAS PLACED.

  Patient problems: Prolapse

  MAUDE report 19054271 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED ADHESIONS, MESH EXPOSURE AND EROSION.

  Patient problems: Adhesion(s); Erosion

  MAUDE report 18710883 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 6/15/2023 INCLUDING PATIENT SYMPTOMS OF VAGINAL DISCHARGE AND BLEEDING.

  Patient problems: Abnormal Vaginal Discharge; Burning Sensation; Dyspareunia; Fecal Incontinence; Hematuria; Intermenstrual Bleeding; Kidney Infection; Micturition Urgency; Neuralgia; Pain; Prolapse; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 17035577 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 6/19/2023 INDICATES THAT THE PATIENT EXPERIENCED EROSION OF THE WHITE SUTURE.

  Patient problems: Erosion; Fecal Incontinence; Micturition Urgency; Pain; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 16996773 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED COMPLICATIONS ASSOCIATED WITH THE DEVICE, EROSION, BLEEDING, PELVIC PAIN, RECURRENCE, ABNORMAL VAGINAL DISCHARGE, MICTURITION URGENCY, ABDOMINAL PAIN, VAGINAL CUFF DEHISCENCE, SKIN IRRITATION AND DIFFICULTY WITH DAILY ACTIVITIES INCLUDING SEXUAL INTERCOURSE. THE PATIENT HAD EXPLANTATION OF THE DEVICE.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Dyspareunia; Erosion; Genital Bleeding; Micturition Urgency; Pain; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 16566154 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED SEVERE PELVIC PAIN, URINARY URGENCY PROBLEMS, INCONTINENCE, SCARRING, RECURRENCE, COLOVAGINAL FISTULA, AND DIFFICULTY WITH DAILY ACTIVITIES. PATIENT HAD THE DEVICE EXPLANTED. PATIENT THEN HAD ANOTHER SURGICAL INTERVENTION.

  Patient problems: Micturition Urgency; Pain; Scar Tissue; Urinary Incontinence; Vesicovaginal Fistula

  MAUDE report 16565659 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED LOWER PELVIC CRAMPING, PAIN THAT RUNS FROM LOWER BACK TO VAGINAL AREA, INCOMPLETE BLADDER EMPTYING, POST VOID INCONTINENCE, LATERAL CYSTOCELE, RECTOCELE, VAGINAL VAULT PROLAPSE, DYSURIA, STANDING TO FULLY EMPTY BLADDER, LATERAL CYSTOCELE, RECTOCELE, VAGINAL VAULT PROLAPSE, PELVIC PAIN WITH SHARP PAINS THROUGHOUT LEFT GROIN AND RECURRENT ANTERIOR PROLAPSE WITH INCOMPLETE BLADDER EMPTYING THAT CAUSES RECURRENT URINARY TRACT INFECTIONS. PATIENT HAD A CYSTOSCOPY THAT NOTED ERYTHEMA CONSISTENT WITH INCOMPLETE BLADDER EMPTYING AND NO SIGNS OF EROSION, KINKING OR OTHER ABNORMALITIES. PATIENT HAD A ROBOTIC ASSISTED SACROCOLPOPEXY, PARAVAGINAL REPAIR, REVISION OF THE UNKNOWN PELVIC DEVICE, RELEASE OF A PRIOR PUBO-URETHRAL DEVICE FROM ANOTHER MANUFACTURER AND WAS DISCHARGED WITH A CATHETER.

  Patient problems: Abdominal Cramps; Dysuria; Erythema; Pain; Prolapse; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 16189111 ↗
• InjuryJan 17, 2023Migration; Migration

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED PELVIC PAIN, LOWER ABDOMINAL PAIN, DYSURIA, DYSPAREUNIA, VAGINAL DISCHARGE, CANDIDA VAGINITIS, URINARY ANALYSIS WITH SMALL LEUKOCYTES, CYSTOSCOPY, PELVIC PAIN, HIP PAIN, EROSION OF IMPLANTED VAGINAL DEVICE AND OTHER PROSTHETIC MATERIALS. PATIENT HAD AN EMERGENCY DEPARTMENT VISIT FOR URINARY FREQUENCY, VAGINAL DISCHARGE, AND BACK PAIN. PATIENT HAD A VAGINAL EXPLORATION WITH DEVICE EXPLANTATION FOR TRANSVAGINAL DEVICE EXPOSURE UNDER GENERAL ANESTHESIA AND ESTIMATED BLOOD LOSS 25 ML.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Dyspareunia; Dysuria; Erosion; Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Pain; Urinary Frequency / Polyuria

  MAUDE report 16183786 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED RECURRENT CYSTOCELE, ANTERIOR VAGINAL WALL PROLAPSE, AND RECURRENT PARAVAGINAL DEFECT. PATIENT HAD IMPLANT OF ANOTHER MANUFACTURER'S SOFT TISSUE REPAIR MATRIX DEVICE FOR CYSTOCELE REPAIR AND ANTERIOR VAGINAL WALL PROLAPSE REPAIR WITH SACROSPINOUS LIGAMENT FIXATION WITH ANOTHER MANUFACTURER'S FIXATION DEVICE AND PROLENE SUTURE, VAGINAL MUCOSA TRIMMING, RIGHT PARAVAGINAL DEFECT REPAIR, AND CYSTOSCOPY. INTRAOPERATIVE FINDINGS NOTED GOOD APICAL AND POSTERIOR WALL SUPPORT.

  Patient problems: Prolapse

  MAUDE report 16178663 ↗