BEUDAMED
    FDA Adverse Event Other Summary report: N

    KNIFE

    MDR report key: 2111154 · Received May 26, 2011

    Report

    Report Number
    2523835-2011-00051
    Event Type
    Other
    Date Received
    May 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN PRODUCT SAMPLE FOR EVAL. THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE KNIVES ARE NOT SHARP ENOUGH AND OFTEN A SUTURE IS REQUIRED TO CLOSE THE INCISION. THE OUTCOME OF THE PATIENTS INVOLVED ARE UNK. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992245 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other