BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLD THERAPY

    MDR report key: 8171331 · Received December 17, 2018

    Report

    Report Number
    1516825-2018-00020
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Report Date
    December 12, 2018
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, LLC
    Product Code
    ILO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETERMINED THAT THE MACHINING DIE DETAIL WAS DAMAGED. THE DIE WAS REPAIRED TO CORRECT.

    Additional Manufacturer Narrative · 1

    USER REPORTED A CT-99 PAD LEAKED ON A PATIENT'S SURGICAL SITE. CSZ OPENED COMPLAINT (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED A CT-99 PAD LEAKED ON A PATIENT'S SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011894 COLD THERAPY COLD THERAPY PAD ILO CINCINNATI SUB-ZERO PRODUCTS, LLC CT-99

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown