BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRITIKON SOFT-CUFF

    MDR report key: 7957351 · Received October 10, 2018

    Report

    Report Number
    MW5080497
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    April 6, 2018
    Report Date
    October 7, 2018
    Manufacturer
    GENERAL ELECTRIC CO / CRITIKON DE MEXICO S. DE R. L. DE C.V.
    Product Code
    DXQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    WIFE CONTRACTED A SEVERE CASE OF CONTACT DERMATITIS RESULTING FROM USE OF CRITIKON SOFT-CUFF BLOOD PRESSURE CUFF AFTER BEING RELEASED FROM (B)(6) HOSP IN (B)(6). CUFF WAS USED FOR CONTINUOUS MONITORING OF BLOOD PRESSURE FOR APPROX 24-28 HOURS. SHE HAS A DOCUMENTED ALLERGIC REACTION TO LATEX, BUT WE WERE TOLD BY (B)(6) HOSP IN (B)(6), THAT THE HOSP IS LATEX FREE. WE CONTACTED (B)(6) IN AN EFFORT TO DETERMINE THE MATERIAL USED IN FABRICATING THE CUFF. WE HAD ONE PHONE CONVERSATION WITH A REP OF GENERAL ELECTRIC AND WE HAVE HAD VERY LIMITED CONTACT WITH THE RISK MGMT OFFICE OF (B)(6). NETHER (B)(6) NOR (B)(6) WILL OR CAN TELL US THE MATERIALS USED IN THE CUFF. WE ARE CONCERNED THAT UNLESS WE CAN DETERMINE THAT MATERIAL(S) IS USED IN THE CUFF THAT CREATES THE DERMATITIS, THE PROBLEM WILL REPEAT ITSELF IF SHE IS EXPOSED TO THE SAME PRODUCT FOR AN EXTENDED PERIOD OF TIME AT A LATER DATE. AS WE UNDERSTAND, THE PRODUCT IS DISPOSABLE AND HAS BEEN ELIMINATED. HOWEVER, OTHER CUFFS IDENTICAL TO HERS SHOULD BE AVAILABLE FROM THE HOSP PICTURES OF HER ARM ARE AVAILABLE UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795494 CRITIKON SOFT-CUFF BLOOD PRESSURE CUFF DXQ GENERAL ELECTRIC CO / CRITIKON DE MEXICO S. DE R. L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other