BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANNUS RETENTION SYSTEM

    MDR report key: 13306547 · Received January 20, 2022

    Report

    Report Number
    13306547
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 8, 2021
    Report Date
    January 10, 2022
    Manufacturer
    TZ MEDICAL, INC.
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TZ MEDICAL PANNUS RETENTION SYSTEM USED DURING CASE ON CATHETERIZATION LAB. BILATERAL SKIN TEARS, NOTED ON THE GROIN AREA OF THE PATIENT, REQUIRED SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490120 PANNUS RETENTION SYSTEM TABLE, OPERATING-ROOM, PNEUMATIC FWW TZ MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Unknown Other