BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNNA FLEX

    MDR report key: 184529 · Received March 13, 1998

    Report

    Report Number
    MW1014496
    Event Type
    Other
    Date Received
    March 13, 1998
    Date of Event
    March 5, 1998
    Report Date
    March 12, 1998
    Manufacturer
    CONVATEC, A BRISTOL-MYERS SQUIBB CO.
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF PAIN AND BURNING DUE TO CONVATEC UNNA BOOT PRODUCT. SWITCHED TO PRIMER UNNA BOOT, AND PT DID NOT EXPERIENCE THE SAME DISCOMFORT. NURSE DID NOT MAKE ANY ADJUSTMENTS IN WRAPPING LEG ON BOTH OCCASSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNNA FLEX UNNA BOOT MGQ CONVATEC, A BRISTOL-MYERS SQUIBB CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other