BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO TRANSITIONAL MEMBER RDL, SHORT

    MDR report key: 10452780 · Received August 26, 2020

    Report

    Report Number
    3003923584-2020-00021
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    June 24, 2020
    Report Date
    July 1, 2020
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K032331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED, BUT AS THERE WAS A POTENTIAL RISK REPORTED ("SCREW BROKE") WE DECIDED TO REPORT THIS CASE. EVALUATION IS ONGOING. WE WILL PERFORM A FOLLOW-UP REPORT AS SOON AS IT IS FINISHED.

    Description of Event or Problem · 1

    CUSTOMER SERVICE WAS CONTACTED FROM DISTRIBUTOR ON (B)(6). CUSTOMER STATED THAT THE SCREW OF THE PRODUCT SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922381 DORO TRANSITIONAL MEMBER RDL, SHORT DORO TRANSITIONAL MEMBER RDL, SHORT HBL PRO MED INSTRUMENTS GMBH 3032-20

    Patients

    Seq Age Sex Outcome Treatment
    1