BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEUR-ERAC A-8000-08L

    MDR report key: 549378 · Received October 19, 2004

    Report

    Report Number
    1221601-2004-00002
    Event Type
    Other
    Date Received
    October 19, 2004
    Report Date
    September 28, 2004
    Manufacturer
    TELEFLEX MEDICAL, INC.
    Product Code
    GCX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED OF THE INCIDENT BY HOSPITAL. THE CUSTOMER REPORTED THAT THE TUBE KINKED AND CAUSED A PNEUMOTHORAX. THERE WAS NO FURTHER COMPLICATION REPORTED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR-ERAC A-8000-08L CHEST DRAIN GCX TELEFLEX MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other