BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 473218 · Received July 18, 2003

    Report

    Report Number
    2210968-2003-00260
    Event Type
    Malfunction
    Date Received
    July 18, 2003
    Date of Event
    May 6, 2003
    Report Date
    June 18, 2003
    Manufacturer
    AVAIL MEDICAL PRODUCTS
    Product Code
    GCY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THEY BEGAN USE OF THE RESERVOIR IN 04/2003. THE RESERVOIR WAS DISCHARGED ONCE OR TWICE DAILY. IN 2003, IT WAS NOTED THE RESERVOIR HAD EXPANDED AND AN AIR LEAKAGE WAS FOUND AT THE HEAT SEAL PLASTIC TAPE WAS USED TO COVER THE OPENING. THE RESERVOIR WAS REPLACED IN 05/2003. THERE WERE NO ADVERSE PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM GCY AVAIL MEDICAL PRODUCTS NA 223598

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN