BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOURNIQUET DISPO CUFF

    MDR report key: 16960539 · Received May 19, 2023

    Report

    Report Number
    16960539
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 24, 2023
    Report Date
    May 2, 2023
    Manufacturer
    VBM MEDIZINTECHNIK GMBH
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STERILE SINGLE USE TOURNIQUET CUFF (VBM MEDIZINTECHNIK GMBH, REF# 20-36-727SLZ-1, LOT # 0000247451) DID NOT ADEQUATELY PERFORM FUNCTION OF A TOURNIQUET. THIS RESULTED IN MORE BLEEDING THAN EXPECTED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874159 TOURNIQUET DISPO CUFF TOURNIQUET, PNEUMATIC KCY VBM MEDIZINTECHNIK GMBH 20-36-727SLZ-1 0000247451

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA Unknown Other