BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESTIGE MEDICAL A2 ANEROID BLOOD PRESSURE UNIT

    MDR report key: 3926640 · Received July 3, 2014

    Report

    Report Number
    MW5037099
    Event Type
    Other
    Date Received
    July 3, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PRESTIGE MEDICAL
    Product Code
    DXN
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PURCHASED A "PRESTIGE MEDICAL A2 ANEROID BLOOD PRESSURE UNIT BLACK WITH NEON STETHOSCOPE, NEON YELLOW" FROM "(B)(4)" A SELLER ON (B)(4). THE ITEM WAS DESCRIBED AS LATEX FREE. UPON RECEIPT, I IMMEDIATELY STARTED TO SUFFER FROM A LATEX REACTION, RASH ON HANDS, BURNING SENSATION IN MOUTH, DIFFICULTY BREATHING, ASTHMA, WITHIN MINUTES THE REACTION MOVED TO ANAPHYLAXIS AND REQUIRED THE USE OF MY EPIPEN. MY SERVICE DOG HIT ON THE BP CUFF AS THE SOURCE OF THE NRL WHICH CAUSED MY REACTION. INJURY, FIRST AID RECEIVED BY NON-MEDICAL PROFESSIONAL. WEBSITE DESCRIPTION STATES "INCLUDES A 6 INCH X 9 INCH COLOR -MATCHED NYLON CARRYING CASE. LIFETIME CALIBRATION WARRANTY LATEX FREE. STANDARD INFLATION BULB AND AIR RELEASE VALVE. FULL ACCESSORY POUCH FOR SPRAGUE-RAPPAPORT INCLUDED. PRODUCT CATEGORY: PERSONAL CARE. EXPLANATION: RETURNING/ REFUND VIA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389108 PRESTIGE MEDICAL A2 ANEROID BLOOD PRESSURE UNIT BLOOD PRESSURE UNIT DXN PRESTIGE MEDICAL A2

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR