BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNNA-FLEX

    MDR report key: 22708 · Received June 22, 1995

    Report

    Report Number
    MW1006317
    Event Type
    Other
    Date Received
    June 22, 1995
    Date of Event
    January 1, 1995
    Report Date
    March 3, 1995
    Manufacturer
    CONVATEC, DIV OF E.R. SQUIBB & SONS, INC.
    Product Code
    FQL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OUR CONVATEC PHYSICIAN HAS REVIEWED ALL OF THE AVAILABLE INFO & NOTES THAT DIAGNOSTIC TESTING WAS NOT PERFORMED TO DETERMINE THE ETIOLOGY OF THE PT'S DERMATITIS. WITHOUT DEFINITIVE DIAGNOSTIC TESTING OR METHODICAL ELIMINATION OF SUSPECT AGENTS, A CAUSAL RELATIONSHIP TO ANY AGEN IS AT BEST SPECULATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNNA-FLEX COMPRESSION DRESSING FQL CONVATEC, DIV OF E.R. SQUIBB & SONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other