BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLACH FREEZER

    MDR report key: 29075 · Received December 26, 1995

    Report

    Report Number
    MW1007999
    Event Type
    Injury
    Date Received
    December 26, 1995
    Date of Event
    October 6, 1993
    Report Date
    December 14, 1995
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Product Code
    HQA
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN THE DEFROST TRIGGER WAS PRESSED WHILE FREEZING A WART ON THE LOWER EYELID, THE TIP OF THE UNIT BLEW OFF AND IMBEDDED IN THE PT'S EYE. PT HAD MULTIPLE SURGERIES ON RT EYE BUT LOST VISION DUE TO THE PENETRATING EYE INJURY. MALPRACTICE CASE ENSUED AND THE PT SETTLED OUT OF COURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLACH FREEZER CRYOSURGICAL INSTRUMENT HQA WALLACH SURGICAL DEVICES, INC. LL100

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| S