BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLO LAB

    MDR report key: 710089 · Received April 7, 2006

    Report

    Report Number
    710089
    Event Type
    Other
    Date Received
    April 7, 2006
    Date of Event
    March 22, 2006
    Report Date
    April 7, 2006
    Manufacturer
    PARKS MEDICAL ELECTRONICS, INC
    Product Code
    DXN
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING LEG ARTERIAL ASSESSMENT. DURING INFLATION OF BP CUFFS W/ FLO LAB, PT EXPERIENCED PAIN. FOLLOWING DEFLATION, A RT THIGH HEMATOMA WAS NOTED. THREE DAYS LATER, PT ALSO DEVELOPED LARGE BLISTER AT SAME SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO LAB CUFF, BP DXN PARKS MEDICAL ELECTRONICS, INC 2100-SX *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR