BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 1191113 · Received September 26, 2008

    Report

    Report Number
    2210968-2008-00905
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/26/2008. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE LOT NUMBER OF THE DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: 47835ISP MFG: 05/14/2008, EXP: 06/30/2013; LOT: 47901ISP, MFG: 05/29/2008, EXP: 06/30/2013; LOT: 47696ISP, MFG: 04/21/2008, EXP: 05/31/2013; LOT: 47766ISP, MFG: 04/30/2008, EXP: 05/31/2013; LOT: 47635ISP, MFG: 04/08/2008, EXP: 04/30/2008. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTS THAT THE DEVICE INFLATED WITH AIR UPON INITIAL ACTIVATION. THE DEVICE WAS REMOVED FROM SERVICE AND EXCHANGED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DRAIN - SURGICAL - NOT SPECIFIED