BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV DOME PAT 3 PEG, 32

    MDR report key: 2070165 · Received April 25, 2011

    Report

    Report Number
    1818910-2011-07246
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFO REQUIRED IN SEARCHING THE COMPLAINT DATABASE BY PRODUCT LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT; HOWEVER, PROVIDED INFO SUGGESTS THE SIZE DEVICE SELECTED AT THE PREVIOUS SURGERY WAS A CONTRIBUTING FACTOR. ADD'L PROVIDED INFO STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS. BASED ON THE PERFORMED INVESTIGATION, 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 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/OV DOME PAT 3 PEG, 32 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention