BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANNUS RETENTION SYSTEM

    MDR report key: 9314639 · Received November 13, 2019

    Report

    Report Number
    9314639
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    September 28, 2019
    Report Date
    October 8, 2019
    Manufacturer
    TZ MEDICAL, INC.
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UNOPENED PANNUS RETENTION SYSTEM PACK NOTED TO HAVE A HAIR INSIDE THE SEALED PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111198 PANNUS RETENTION SYSTEM TABLE, OPERATING-ROOM, PNEUMATIC FWW TZ MEDICAL, INC. M35640

    Patients

    Seq Age Sex Outcome Treatment
    1