BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE L

    MDR report key: 5039533 · Received August 28, 2015

    Report

    Report Number
    2125050-2015-00086
    Event Type
    Injury
    Date Received
    August 28, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    COLOPLAST CORP
    Product Code
    OTO
    PMA / PMN Number
    K122440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 WAS IMPLANTED WITH RESTORELLE L MESH. LATER THE PATIENT EXPERIENCED LUMBAR / SACRAL DISKITIS, AN INFLAMMATION OF THE VERTEBRAL DISK SPACE OFTEN RELATED TO INFECTION, AND OSTEOMYLETIS (INFECTION); WHERE MESH ATTACHED DURING SACRAL COLPOPEXY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571483 RESTORELLE L SURGICAL MESH OTO COLOPLAST CORP 5014402400 3271630

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R