BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT - KOOL GRIP MALLET - HD

    MDR report key: 2051463 · Received April 4, 2011

    Report

    Report Number
    9610726-2011-00099
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME EVENT AS MFR # 9610726-2011-00097, 9610726-2011-00098.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS TO HAVE PROBLEMS WITH THE HEADS OF THE HAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - KOOL GRIP MALLET - HD INSTRUMENT LXH STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other