BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSE CARE MEDICAL LLC

    MDR report key: 2940834 · Received January 10, 2006

    Report

    Report Number
    2940834
    Event Type
    Other
    Date Received
    January 10, 2006
    Date of Event
    July 5, 2005
    Report Date
    July 8, 2005
    Manufacturer
    PULSE CARE MEDICAL LLC
    Product Code
    KPE
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    PULSE IRRIGATION - WASTE BAG SEALED AROUND WOUND. BOTTOM OF BAG LEAKED THE WASTE WHICH CONTAINS BACTERIA. PT EXPOSED TO BACTERIA BUT NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE CARE MEDICAL LLC PLASTIC BAG KPE PULSE CARE MEDICAL LLC ADH 200

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other