BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXIPULSE FOOT WRAPS

    MDR report key: 226533 · Received May 28, 1999

    Report

    Report Number
    1648561-1999-00003
    Event Type
    Other
    Date Received
    May 28, 1999
    Report Date
    May 28, 1999
    Manufacturer
    KCI NEW TECHNOLOGIES INC.
    Product Code
    JOW
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT A PATIENT IN ANOTHER DOCTOR'S CLINICAL STUDY DEVELOPED BLISTERS UNDER THE RIGHT FOOT AND PARTS OF THE SIDE OF THE FOOT. THE BLISTERS WERE INITIALLY CLEAR THEN TURNED RED AND BROWN AND THE CIRCUMFERENCE OF THE BLISTERED AREA WAS APPROX. 4 INCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXIPULSE FOOT WRAPS COMPRESSION LIMB SLEEVE JOW KCI NEW TECHNOLOGIES INC. 235342 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other