BEUDAMED
    FDA Adverse Event Summary report: N

    NU-GAUZE IODOFORM PACKING SLIP

    MDR report key: 21615 · Received April 4, 1995

    Report

    Report Number
    MW4000678
    Date Received
    April 4, 1995
    Report Date
    June 14, 1994
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    GEL
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE RPTR HAS STOPPED USING THE PRODUCT BECAUSE HE HAS NOT RECEIVED A SATISFACTORY ANSWER FROM THE MFR AS TO WHY 20 YEARS OF BEING YELLOW IN COLOR THE PRODUCT IS NOW WHITE. HE WOULD LIKE TO KNOW IF THE PRODUCT CONTAINS IODOFORM AND WHETHER OR NOT HE CAN RELY ON IT BEING BACTERIOSTATIC. THE RPTR STATED THAT THERE WAS NO INDICATION ON THE LABEL THAT THE COLOR OF THE PRODUCT HAD BEEN CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NU-GAUZE IODOFORM PACKING SLIP PACKING STRIP GEL JOHNSON & JOHNSON 291071

    Patients

    Seq Age Sex Outcome Treatment
    1 *