BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF

    MDR report key: 5041728 · Received August 25, 2015

    Report

    Report Number
    MW5055833
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    June 30, 2015
    Report Date
    August 25, 2015
    Manufacturer
    WELCH ALLYN
    Product Code
    DXQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTING ON WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF. HOSPITALIZED AT (B)(6), (B)(6) 2015. EVERY TIME MY BLOOD PRESSURE WAS TAKEN, THE CUFF HURT MY ARM A LOT! ONE TIME, THE NURSE OBVIOUSLY DIDN'T HAVE THE CUFF PLACED CORRECTLY, BECAUSE ONE SIDE OVERLAPPED THE INNER PORTION OF MY ELBOW AND LEFT A BURNING PRESSURE MARK THAT TOOK A FEW DAYS TO FADE AWAY. NURSES SAID OTHER PATIENTS HAD COMPLAINED ALSO. IN FOLLOW UP WITH MY OWN PHYSICIAN AT (B)(6), SAME THING HAPPENED. DOCTOR OPINED THAT IT WAS BECAUSE MY BLOOD PRESSURE WAS HIGH, BUT EVEN WHEN IT WASN'T, THE CUFF HURT. I DON'T KNOW IF NURSES DON'T KNOW THE CORRECT SIZE TO USE ON MY ARM, IF THE PRESSURE COMING FROM THE MACHINE IS TOO STRONG, OR WHAT ELSE MIGHT BE WRONG, BUT I DON'T BELIEVE THIS IS A GOOD OUTCOME. EVEN WITH HIGH BLOOD PRESSURE, THE OLD-STYLE CUFFS NEVER HURT THIS WAY. IF IT HAPPENS AGAIN, I AM GOING TO HAVE TO REFUSE TO HAVE MY BLOOD PRESSURE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560169 FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF DXQ WELCH ALLYN ADULT 11 25-34 CM

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR GABAPENTIN 300 MG QD