BEUDAMED
    FDA Adverse Event Other Summary report: N

    LARGE ADULT D-RING CUFF (13" - 17")

    MDR report key: 2249672 · Received August 25, 2011

    Report

    Report Number
    1450057-2011-00003
    Event Type
    Other
    Date Received
    August 25, 2011
    Report Date
    August 25, 2011
    Manufacturer
    OMRON (DALIAN) CO., LTD. (PLANT 1), ECONOMIC & TECHNICAL DEVELOPMENT ZONE
    Product Code
    DXN
    PMA / PMN Number
    K052153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RN CLAIMS SHE HAS PROVIDED OVER 100 OMRON UNITS TO PROGRAM PARTICIPANTS AND THIS THE 1ST EVENT OF THIS NATURE SHE HAS EXPERIENCED WITH AN END-USER CLIENT. THE DISTRIBUTER IS AWAITING THE BASE UNIT AND COMPONENT CUFF FROM THE HEALTH CARE PROFESSIONAL FOR EVALUATION. AN INVESTIGATION OF THE EVENT HAS BEEN INITIATED. A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA PENDING RETURN OF THE UNIT AND CUFF FOR EVALUATION. ON INITIAL COMMUNICATION WITH MFR, THE MFR INDICATED THE CUFF IS LATEX FREE.

    Description of Event or Problem · 1

    RN CLAIMS PT HAD A BAD SKIN REACTION ON HER UPPER ARM WHERE THE LARGE BP CUFF HAD BEEN PLACED. CLAIMS THE AREA WAS RAISED AND RED AND APPEARED TO BE 'CONTACT DERMATITIS.' RN CLAIMS PT IS ALLERGIC TO LATEX AND ALSO HAS A HISTORY OF ASTHMA. CLAIMS PT IS ON RX HYPERTENSION MEDICATION AND PREDNISONE FOR THE ASTHMA. CLAIMS PT WAS ADMINISTERED AS DOSE BENADRYL AND SENT HOME WITH HYDROCORTISONE CREAM. RN STATES PT RECEIVED IMMEDIATE RELIEF AND HAS NOT REPORTED ANY ONGOING SYMPTOMS WITHIN THE LAST TWO WEEKS. PT DUE BACK FOR ROUTINE MONTHLY CLASS AND APPOINTMENT IN (B)(6) WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE ADULT D-RING CUFF (13" - 17") LARGE ADULT D-RING CUFF (13" - 17") DXN OMRON (DALIAN) CO., LTD. (PLANT 1), ECONOMIC & TECHNICAL DEVELOPMENT ZONE H-003D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other