BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE  Y

    MDR report key: 12167779 · Received July 14, 2021

    Report

    Report Number
    2125050-2021-00908
    Event Type
    Injury
    Date Received
    July 14, 2021
    Report Date
    February 25, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTO
    PMA / PMN Number
    K112322
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT NUMBER: 110318-01

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT THE PATIENT ALSO EXPERIENCED: CHRONIC YEAST INFECTIONS, RASHES AND HAIR LOSS, HISPAREUNIA (HER HUSBAND'S PENIS CAUGHT DURING INTERCOURSE), DIFFICULTY WITH URINARY EMPTYING, OCCASIONAL DYSURIA, LEFT LEG PAIN WITH NUMBNESS AND TINGLING, POSSIBLE MESH EXPOSURE, SUPERFICIAL EROSION INTO THE POSTERIOR FORNIX, AND URGENCY.

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE IN ADDITION TO A COMPETITOR'S DEVICE EXPERIENCED PELVIC, RECTAL, LOW BACK, VAGINAL, ABDOMINAL AND UPPER THIGH PAIN, RECTAL BLEEDING, DYSPAREUNIA, BLEEDING AFTER INTERCOURSE, URINARY TRACT INFECTIONS, CONSTIPATION, BLOOD WITH BOWEL MOVEMENT. A COLONOSCOPY SHOWED AN ANAL FISSURE. TRANSVAGINAL URETHROLYSIS, ABDOMINAL VAGINAL EXPLORATION OF RETROPUBIC SPACE WAS PERFORMED FOR MESH REMOVAL, LYSIS OF ADHESION, EXCISION OF SACROCOLPOPEXY MESH, CERVICAL HYSTERECTOMY, CLOSURE OF VAGINAL CUFF, AND ANTERIOR VAGINAL WALL RECONSTRUCTION FOR COMPLICATION OF MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062057 RESTORELLE  Y SURGICAL MESH OTO COLOPLAST A/S 5014201400

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization| R