BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR KIT

    MDR report key: 3122164 · Received May 21, 2013

    Report

    Report Number
    2125050-2013-00048
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT IMPLANTED WITH ARIS MESH ON (B)(6) 2011. LATER PATIENT EXPERIENCED PAIN, EMOTIONAL DISTRESS AND PERMANENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224151 ARIS TRANS-OBTURATOR KIT PUBORUETHRAL SUPPORT TAPE FTL COLOPLAST A/S 5195512400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other