BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNERCOOL THERAPIES

    MDR report key: 1327331 · Received February 25, 2009

    Report

    Report Number
    MW5010098
    Event Type
    Malfunction
    Date Received
    February 25, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 25, 2009
    Manufacturer
    INNERCOOL THERAPIES, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LEFT LEG PAD ON TWO INNERCOOL PADS LEAKED THE DISTILLED WATER POSSIBLY FROM THE CONNECTORS. INNERCOOL L/XL KIT THAT CONTAINED A VEST AND ONE LEFT AND RIGHT THIGH PAD AND ONE KIT THAT CONTAINED A THIGH KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERCOOL THERAPIES INNERCOOL SYSTEM DWJ INNERCOOL THERAPIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR