BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLD COMPRESS, PERI PACK IN VAG. DELIV. PACK

    MDR report key: 225141 · Received May 24, 1999

    Report

    Report Number
    1423395-1999-00005
    Event Type
    Other
    Date Received
    May 24, 1999
    Date of Event
    May 4, 1999
    Report Date
    May 6, 1999
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, WHEN A NURSE BURST THE INNER POUCH TO ACTIVATE THE COMPRESS, THE OUTER POUCH BURST AND THE CONTENTS GOT ON HER CLOTHES AND IN HER EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLD COMPRESS, PERI PACK IN VAG. DELIV. PACK COLD COMPRESS BTI MEDLINE INDUSTRIES, INC. * 6538-8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other