BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE

    MDR report key: 40163 · Received August 29, 1996

    Report

    Report Number
    2183819-1996-00001
    Event Type
    Malfunction
    Date Received
    August 29, 1996
    Date of Event
    July 5, 1996
    Report Date
    August 1, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA PROCEDURE, THE BALLON WOULD NOT DEFLATE. A SYRINGE WAS USED TO DEFLATE THE BALLOON. NO PT INJURIES OR COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE BALLOON DILATATION INFLATION DEVICE MAV SCIMED LIFE SYSTEMS, INC. SM2500 E060396

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PTCA BALLOON CATHETER (UNKNOWN MFR & MODE)