BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH BLUNT CHERRY DISSECTOR

    MDR report key: 133018 · Received November 13, 1997

    Report

    Report Number
    1527736-1997-03011
    Event Type
    Malfunction
    Date Received
    November 13, 1997
    Report Date
    October 15, 1997
    Manufacturer
    CARWILD CORPORATION
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE SPONGE GETS LOOSE FROM THE DEVICE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH BLUNT CHERRY DISSECTOR BLUNT CHERRY DISSECTOR KNS CARWILD CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other