BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJ. OPTIV DH, W/OEM

    MDR report key: 15209843 · Received August 11, 2022

    Report

    Report Number
    1518293-2022-00007
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Report Date
    July 15, 2022
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) CHINA ON (B)(6) 2022. THE REPORTER STATES THAT WHILE THE DOCTOR WAS PREPARING TO USE THE POWERHEAD, THE EXTENSION/SPRING ARM (PN:241063) SUDDENLY FELL. FORTUNATELY, THE DOCTOR HELD THE POWERHEAD IN HIS HAND AND DIDN'T LET THE POWERHEAD FALL TO THE GROUND CAUSING MORE DAMAGE. THERE WAS NO PATIENT INVOLVEMENT AND THE POWERHEAD WAS HELD BY DOCTOR WHEN IT CAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163672 INJ. OPTIV DH, W/OEM INJ. OPTIV DH, W/OEM IZQ LIEBEL-FLARSHEIM 844007 C0921B652G

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown