BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-VAC RESERVOIR

    MDR report key: 1842858 · Received September 17, 2010

    Report

    Report Number
    2210968-2010-01145
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    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

    (B)(4): CONCLUSION: 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. ADDITIONAL INFO: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS. BATCH 50468ISP MFG DATE: 11/06/2009, EXP DATE: 11/30/2014. BATCH 50469ISP MFG DATE: 11/20/2009, EXP DATE: 08/31/2014. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01142, 01143, AND 01144. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6)2010. A DRAIN WAS PLACED AND A RESERVOIR WAS CONNECTED. AFTER CLOSING THE SURGICAL WOUND SITE, THE SURGEON FOUND THE RESERVOIR COULD NOT INFLATE. THEN THE SURGEON TRIED TO BLOW OUT THE RESERVOIR, BUT THE RESERVOIR STILL COULD NOT INFLATE. THE SURGEON SUSPECTED THAT THE ANTI-REFLUX VALVE OF THE RESERVOIR WAS THE DEFECT. THE SURGEON CUT OPEN A PART OF THE SUTURED FASCIA (NOT OPEN STERNA BONE) TO EXCHANGE THE DRAIN AND THEN REPLACED THE RESERVOIR. THE PT IS HOSPITALIZED AND RECOVERING NOW.

    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 76 YR Required Intervention