BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLD THERAPY PAD

    MDR report key: 1898395 · Received October 28, 2010

    Report

    Report Number
    1516825-2010-00016
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    December 23, 2008
    Report Date
    December 23, 2008
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED BASED ON A RECENT INTERNAL AUDIT OF COMPLAINT FILES. UPON REVIEW OF THE FILES, IT WAS OBSERVED THAT THIS COMPLAINT SHOULD HAVE BEEN FILED, BUT WASN'T. DEVICE WAS EVALUATED BY CSZ AND CONFIRMED THAT THE RETURNED PAD LEAKED AS A RESULT OF SEAL SEPARATION. A REVIEW OF OUR COMPLAINT DATABASE SHOWS THAT THE CURRENT FAILURE RATE OF THE CT-99 IS APPROX 0.189% OVER THE LAST 3 YEARS. CSZ WILL CONTINUE TO MONITOR ALL COMPLAINTS FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A PT HAD KNEE SURGERY AND A CT-99 WAS PLACED ON THE PT'S KNEE. THE CT-99 LEAKED SOAKING THE PT'S DRESSING WITH WATER FROM THE CT-99. THERE WAS CONCERN THAT THERE IS A POTENTIAL RISK THAT WATER LEAKED INTO THE PT'S DRESSING AND POSSIBLE RISK OF INFECTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLD THERAPY PAD WATER CIRCULATING HOT OR COLD PACK DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. CT-99 06773

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention