BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNNAFLEX

    MDR report key: 22710 · Received June 22, 1995

    Report

    Report Number
    MW1006318
    Event Type
    Other
    Date Received
    June 22, 1995
    Date of Event
    March 5, 1995
    Report Date
    March 15, 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

    CONVATEC PHYSICIAN HAS REVIEWED ALL OF THE AVAILABLE INFO AND NOTES THAT DIAGNOSTIC TESTING WAS NOT PERFORMED TO DETERMINE THE ETIOLOGY OF THE PT'S DERMATITIS. IT IS POSSIBLE THAT THE DERMATITIS WAS DUE TO SENSITIZATION TO ZINC OXIDE OR ANOTHER COMPONENT OF UNNAFLEX ELASTIC UNNA BOOT. HOWEVER, DERMATITIS MAY BE RELATED TO A VARIETY OF CAUSATIVE AGENTS RANGING FROM CONCOMITANT MEDICATIONS TO SOAPS OR LOTIONS. WITHOUT DEFINITIVE DIAGNOSTIC TESTING OR METHODICAL ELIMINATION OF SUSPECT AGENTS, A CAUSAL RELATIONSHIP TO ANY AGENT IS AT BEST SPECULATIVE. BASED UPON CO'S EVALUATION, FREQUENCY AND SEVERITY DATA DOES NOT SHOW AN INCREASE AND DOES NOT MARKEDLY DIFFER FROM WHAT IS CONSIDERED USUAL FOR THIS DEVICE. FURTHERMORE, CONVATEC HAS DETERMINED THAT THIS INCIDENT IS NOT REPORTABLE AS IT DOES NOT MEET THE CRITERIA FOR REPORTABILITY UNDER THE MEDICAL DEVICE REPORTING REGULATION 21 CFR, SECTION 803.24.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DAY Other