BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 1002273 · Received February 20, 2008

    Report

    Report Number
    1818910-2008-00682
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS FOR THE MFG LOTS. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED PAIN. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/OV/DOME PAT 3PEG,35 87JWH JWH DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS NA 2399858

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention