BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASCAN CPG HANDPIECE

    MDR report key: 69771 · Received February 14, 1997

    Report

    Report Number
    2914019-1997-00004
    Event Type
    Injury
    Date Received
    February 14, 1997
    Date of Event
    September 30, 1996
    Report Date
    February 14, 1997
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MFG DATA SHOWED THE ULTRASCAN CPG HANDPIECE TO BE WITHIN SPEC WHEN IT WAS MANUFACTURED. UPON RETURN OF THE CPG, SPOT SIZE WAS MEASURED & FOUND TO BE SLIGHTLY OUT OF SPEC. THIS DESIGN WAS PREVIOUSLY [UPGRADED/CHANGED] VIA A FACTORY RETURN PROGRAM TO REDUCE VARIABILITY BETWEEN THE PERFORMANCE OF EACH HANDPIECE, HOWEVER THE INTERNATIONAL CUSTOMER ELECTED TO NOT RETURN OR UPGRADE THEIR DEVICE. THE UPGRADED VERSION OF THE ULTRASCAN CPG HANDPIECE HAVE BEEN SHIPPED TO ALL DOMESTIC CUSTOMERS. THREE INTERNATIONAL AREAS HAVE CHOSEN NOT TO RETURN THEIR CPG'S FOR UPGRADES.

    Description of Event or Problem · 1

    BURNS ON FACE OF PT DURING TOTAL FACILA RESURFACING. PICTURES RECIEVED ON 1/23/97 SHOW PITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASCAN CPG HANDPIECE SURGICAL DELIVERY DEVICES GEX COHERENT MEDICAL GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other