BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH-CHLORHEXEDINE

    MDR report key: 279009 · Received May 19, 2000

    Report

    Report Number
    MW1018957
    Event Type
    Other
    Date Received
    May 19, 2000
    Date of Event
    April 1, 2000
    Report Date
    May 19, 2000
    Manufacturer
    JOHNSON AND JOHNSON MEDICAL DIV. ETHICON, INC.
    Product Code
    FRO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PARENTS REPORT SKIN BREAKDOWN AT HICKMAN SITE. SEEN IN LOCAL ER. ER PHYSICIAN DISCONTINUED BIOPATCH DUE TO SKIN IRRITATION. PARENTS REPORT DRAMATIC SKIN IMPROVEMENT AFTER BIOPATCH DISCONTINUED. THERAPY DATES: WEEKLY FOR 2 MOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH-CHLORHEXEDINE * FRO JOHNSON AND JOHNSON MEDICAL DIV. ETHICON, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other 1) VELBAN MONTHLY.