BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/RD/DOME PAT 3 PEG, 35

    MDR report key: 2232765 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15059
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: MFG. FACILITY NAME. THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT CODE/LOT CODE COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR WITHOUT THE PRODUCT TO EXAMINE. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT REVISED FOR PAIN, POLYETHYLENE WEAR NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/RD/DOME PAT 3 PEG, 35 87JWH JWH CODMAN AND SHURTLEFF - RAYNHAM NA 191924

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention