BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 821161 · Received January 19, 2007

    Report

    Report Number
    2210968-2007-00048
    Event Type
    Malfunction
    Date Received
    January 19, 2007
    Date of Event
    December 14, 2006
    Report Date
    December 27, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN REC'D, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF EIGHT MEDWATCH REPORTS BEING SUBMITTED AS EIGHT SEPARATE DEVICES WERE USED. SEE 2210968-2007-00042, 2210968-2007-00043, 2210968-2007-00044, 2210968-2007-00045, 2210968-2007-46, 2210968-2007-00047, 2210968-2007-00048, AND 2210968-2007-00049 FOR ALL ASSOCIATED REPORTS. THE SAME PT IS REPRESENTED IN EACH MEDWATCH. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT 44753ISP-MFG DATE: 8/3/2006 -EXP DATE: 9/30/2011, LOT 44820ISP- MFG DATE: 8/18/2006 -EXP DATE: 9/30/2011.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE READILY INFLATED WITH AIR FROM A LEAK AT THE DEVICE CONNECTOR. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    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 YR J-VAC RESERVOIR - CATALOG # 2177