BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG FLUT FEMROD 5DG14X175MM

    MDR report key: 1063267 · Received June 18, 2008

    Report

    Report Number
    1818910-2008-02427
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT/PACKAGING AND REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE SIZE 3 PRODUCT WAS LABELED AS SIZE 2. THE ROOT CAUSE IS ATTRIBUTED TO HUMAN ERROR IN THE LABEL PROCESS. DEPUY CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF THIGH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG FLUT FEMROD 5DG14X175MM 87JWH JWH DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM NA 313496R

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention