BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAIR PAWS

    MDR report key: 1566375 · Received December 8, 2009

    Report

    Report Number
    3004542876-2009-00005
    Event Type
    Other
    Date Received
    December 8, 2009
    Date of Event
    October 23, 2009
    Report Date
    December 7, 2009
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Product Code
    DWJ
    Removal / Correction Number
    NOT YET ASSIGNED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE ADVERSE EVENT OCCURRED ON (B)(6) 2009, WE DID NOT BECOME AWARE OF INFO THAT WOULD LEAD US TO CONCLUDE THAT IT WAS A REPORTABLE EVENT UNTIL NOVEMBER 19, 2009. OUR INITIAL INVESTIGATION FOUND THE EVENT WAS DUE TO UNUSUALLY ABUSIVE USE AND HANDLING AND WAS NOT A DEVICE MALFUNCTION. ADD'L MATERIAL INFO HAS MORE RECENTLY BEEN ACQUIRED FROM INDUSTRY COMMUNICATIONS AND RECALL NOTICES CONCERNING DEFECTIVE AC POWER CORDS MANUFACTURED BY ELECTRI-CORD MFG CORP THAT ALTERED THIS INITIAL CONCLUSION.

    Description of Event or Problem · 1

    REPORT OF ELECTRI-CORD POWER CORD SMOKING AT WALL END PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR PAWS PATIENT WARMING THERAPY DWJ ARIZANT HEALTHCARE INC. 875 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other