BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2183533 · Received June 26, 2011

    Report

    Report Number
    1644019-2011-00027
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ALCON - BELGIUM/ S.A.ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE NOT YET BEEN REC'D FOR EVAL. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION TEST VALUES FOR THE LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A BLUNT KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY'S ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A DULL KNIFE WAS NOTED DURING A PROCEDURE. A SECOND KNIFE WAS OPENED AND USED TO COMPLETE THE INCISION. THERE WAS NO PT OR PROCEDURAL IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ S.A.ALCON-COUVREUR N.V. CUSTOM PAK 834595M

    Patients

    Seq Age Sex Outcome Treatment
    1