BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXUFLOW ROUND 15FR 3/4(HUB)TROCAR P.STER.

    MDR report key: 14538708 · Received May 29, 2022

    Report

    Report Number
    8030107-2022-00004
    Event Type
    Malfunction
    Date Received
    May 29, 2022
    Report Date
    May 29, 2022
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    OTK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO NON-CONFORMITIES DETECTED DURING THE BATCH HISTORY REVIEW AND TESTING OF THE RETAIN SAMPLE. THE DRAIN COULD TEAR DUE TO SOME DAMAGE IN USE. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED; NO CAPA WILL BE REQUIRED IN THIS CASE.

    Description of Event or Problem · 0

    THE TUBE BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878459 EXUFLOW ROUND 15FR 3/4(HUB)TROCAR P.STER. EXUFLOW ROUND 15FR 3/4(HUB)TROCAR P.STER. OTK DEGANIA SILICONE LTD 15FR P2030538

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown