BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE Y

    MDR report key: 10227858 · Received July 3, 2020

    Report

    Report Number
    2125050-2020-00506
    Event Type
    Injury
    Date Received
    July 3, 2020
    Date of Event
    December 15, 2017
    Report Date
    August 25, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTO
    PMA / PMN Number
    K112322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT IN DECEMBER 2017 THE PATIENT WAS EXPERIENCING OR HAD EXPERIENCED VAGINAL MESH EXTRUSION. EXCISION OF ERODED TRANSVAGINAL MESH TOOK PLACE UNDER GENERAL ANESTHESIA. PATHOLOGY: SOFT TISSUE SHOWED CHRONIC INFLAMMATION.

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED SEVERE PAIN WITH DAILY ACTIVITIES, VAGINAL SCARRING, VAGINAL BLEEDING AND DYSPAREUNIA. VAGINAL PROLAPSE, URINARY INCONTINENCE, PHYSICAL DEFORMITY AND THE LOSS OF THE ABILITY TO PERFORM SEXUALLY. PORTION OF MEH EXCISED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692890 RESTORELLE Y SURGICAL MESH OTO COLOPLAST A/S 5014202400

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization| R| O