BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 1141057 · Received August 29, 2008

    Report

    Report Number
    2210968-2008-00767
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: 47369ISP, MFG: 11/30/2007, EXP: 02/28/2013. LOT: 47231ISP, MFG: 01/17/2008, EXP: 01/31/2008. LOT: 47490ISP, MFG: 03/20/2008, EXP: 03/31/2013. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOOD RELEASE CRITERIA.

    Description of Event or Problem · 1

    INT'L CUSTOMER REPORTS THAT THE DEVICE BROKE FIVE DAYS FOLLOWING IMPLANT. THE BROKEN FRAGMENT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM GCY ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK