BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL FLAT DRAIN WITH TROCAR

    MDR report key: 10275751 · Received July 15, 2020

    Report

    Report Number
    8030107-2020-00017
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    July 15, 2020
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    OTK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THERE WERE NO NON-CONFORMITIES DETECTED DURING BATCH HISTORY RECORDS, AND THE IN-PROCESS TEST RESULTS WERE WELL ABOVE THE REQUIRED MINIMUM, WE CONCLUDE THAT THERE WAS NO PROBLEM WITH OUR PART. THE DRAIN MOST LIKELY WAS DAMAGED IN USE AND TORE IN THE DAMAGED AREA; SILICONE DRAINS ARE KNOWN FOR THEIR ABILITY EASILY SNAP IF THEY WERE EVEN LIGHTLY CUT OR NICKED. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED.

    Description of Event or Problem · 1

    BROKEN/CRACKED/FRACTURED DURING USE: FRACTURE AT THE DRAIN TUBE JOINT DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743164 CHANNEL FLAT DRAIN WITH TROCAR SILICONE FLUTED FLAT DRAIN 10 MM OTK DEGANIA SILICONE LTD 10 MM P1757997

    Patients

    Seq Age Sex Outcome Treatment
    1