BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXIPULSE

    MDR report key: 226457 · Received May 28, 1999

    Report

    Report Number
    1648561-1999-00001
    Event Type
    Other
    Date Received
    May 28, 1999
    Date of Event
    January 21, 1997
    Report Date
    May 28, 1999
    Manufacturer
    KCI NEW TECHNOLOGIES INC.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT. 1 ROUND SKIN DISCOLORATION, PROCEEDED TO OPEN ULCER (STAGE II) BUT DID NOT EXTEND DOWN TO ACHILLES TENDON. PT. 2 & 3 - ROUND DISCOLORATION OF THE SKIN (STAGE I). NEITHER ONE DEVELOPED FULL THICKNESS WOUNDS AND DID NOT EXTEND DOWN TO THE ACHILLES TENDON.

    Description of Event or Problem · 2

    PT. 1 - ROUND SKIN DISCOLORATION, PROCEEDED TO OPEN ULCER (STAGE II) BUT DID NOT EXTEND DOWN TO ACHILLES TENDON. PT. 2 & 3 - ROUND DISCOLORATION OF THE SKIN (STAGE I). NEITHER ONE DEVELOPED FULL THICKNESS WOUNDS AND DID NOT EXTEND DOWN TO THE ACHILLES TENDON.

    Description of Event or Problem · 3

    PT. 1 - ROUND SKIN DISCOLORATION, PROCEEDED TO OPEN ULCER (STAGE II) BUT DID NOT EXTEND DOWN TO ACHILLES TENDON. PT. 2 & 3 - ROUND DISCOLORATION OF THE SKIN (STAGE I.) NEITHER ONE DEVELOPED FULL THICKNESS WOUNDS AND DID NOT EXTEND DOWN TO THE ACHILLES TENDON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other
    2 * Other
    3 * Other