BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER

    MDR report key: 16655642 · Received March 31, 2023

    Report

    Report Number
    1211998-2023-00009
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Report Date
    March 30, 2023
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC.
    Product Code
    HNN
    UDI-DI
    00088615800172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY RECEIVED THE (378235) OPTIMUM 15DEG. STRAIGHT W/SAFETY WITH RETRACTED SHIELDS (LOTS 6048339, 6052491, 6052567) . THE CUSTOMER DID NOT SPECIFY THE QUANTITY OF AFFECTED PRODUCT OR THE DATE IN WHICH THEY FOUND THE SHIELDS TO BE RETRACTED. THERE WAS NO INJURY REPORTED TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102036 BEAVER OPTIMUM 15DEG. STRAIGHT W/SAFETY HNN BEAVER-VISITEC INTERNATIONAL, INC. 6048339, 6052491, 6052567 00088615800172

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown