BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLACH LL-100

    MDR report key: 384431 · Received March 14, 2002

    Report

    Report Number
    MW4003219
    Event Type
    Injury
    Date Received
    March 14, 2002
    Date of Event
    January 25, 2002
    Report Date
    February 25, 2002
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE WALLACH CRYO UNIT BECAME DISCONNECTED AND ACTED LIKE A PROJECTILE PENETRATING THE PT'S UPPER LIP AND LODGING IN THE PT'S GUM. THE SPRAY FROM THE UNIT CAUSED A FIRST DEGREE BURN ON THE PT'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLACH LL-100 CRYO UNIT GEH WALLACH SURGICAL DEVICES, INC. LL-100 TIP # AP7AU *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention