BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE Y SHAPED 24X4CM

    MDR report key: 8641916 · Received May 24, 2019

    Report

    Report Number
    2125050-2019-00402
    Event Type
    Injury
    Date Received
    May 24, 2019
    Report Date
    May 23, 2019
    Manufacturer
    COLOPLAST CORP
    Product Code
    OTO
    PMA / PMN Number
    K112322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED SEVERE PAIN WITH DAILY ACTIVITIES AND INTERCOURSE, URINARY INCONTINENCE, PHYSICAL DEFORMITY, AND THE LOSS OF ABILITY TO PERFORM SEXUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433217 RESTORELLE Y SHAPED 24X4CM SURGICAL MESH OTO COLOPLAST CORP 5014202400 10113-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other