BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL ROUND 10FR DRAIN WITH TROCAR

    MDR report key: 10807762 · Received November 9, 2020

    Report

    Report Number
    8030107-2020-00042
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Report Date
    November 9, 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 THE IN-PROCESS REPORTS AND TEST OF RETAIN SAMPLE FROM THE SAME BATCH SHOWED OK RESULTS, WE CONCLUDE THAT THIS SILICONE DRAIN MOST PROBABLY TORE FOLLOWING SOME DAMAGE IN USE.

    Description of Event or Problem · 1

    BROKEN/CRACKED/FRACTURED DURING USE:FRACTURE AT THE DRAIN TUBE JOINT DURING USE. IT BROKE ABOUT 2 CM FROM THE TIP OF THE DRAIN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276316 CHANNEL ROUND 10FR DRAIN WITH TROCAR SILICONE FLUTED ROUND DRAIN 10FR OTK DEGANIA SILICONE LTD 10FR P1941531

    Patients

    Seq Age Sex Outcome Treatment
    1