BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMEDICA LASER LANCET LB100

    MDR report key: 219079 · Received April 15, 1999

    Report

    Report Number
    1648708-1999-00001
    Event Type
    Malfunction
    Date Received
    April 15, 1999
    Date of Event
    March 24, 1999
    Report Date
    April 15, 1999
    Manufacturer
    TRANSMEDICA INTL., INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BATTERY PACK WAS RE-CHARGING IN BATTERY CHARGER. USER NOTICED THAT SMOKE WAS ORIGINATING FROM DEVICE DURING OPERATION. USER BELIEVED THAT RISK OF FIRE WAS IMMEDIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSMEDICA LASER LANCET LB100 LASER PERFORATOR GEX TRANSMEDICA INTL., INC. LB100/CH100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other