BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 821211 · Received January 19, 2007

    Report

    Report Number
    2210968-2007-00054
    Event Type
    Malfunction
    Date Received
    January 19, 2007
    Date of Event
    December 12, 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: 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 FOUR MEDWATCH REPORTS BEING SUBMITTED AS FOUR SEPARATE DEVICES WERE USED. SEE 2210968-2007-00051, 2210968-2007-00052, 2210968-2007-00053 AND 210968-2007-00054 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 A RESERVOIR 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
    2
    3