BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO GAUZE PACKING STRIP/IODOFORM

    MDR report key: 208267 · Received February 2, 1999

    Report

    Report Number
    1618732-1999-00016
    Event Type
    Injury
    Date Received
    February 2, 1999
    Report Date
    January 5, 1999
    Manufacturer
    JOHNSON & JOHNSON MEDICAL
    Product Code
    GEL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SHE HAD AN INFECTED ABDOMINAL INCISION AFTER A CESAREAN SECTION. SHE WAS DISCHARGED TO HOME WITH A HOME CARE AGENCY. HER DOCTOR ORDERED HER WOUND TO BE PACKED WITH PLAIN PACKING STRIPS SOAKED IN A SOLUTION. THIS WAS A CONTINUATION OF WHAT WAS BEING DONE IN THE HOSPITAL PRIOR TO DISCHARGE. THE HOME CARE AGENCY WAS RESPONSIBLE FOR PROVIDING HER SUPPLIES. THEY BROUGHT HER THE PACKING STRIPS WITH IODOFORM. THIS PRODUCT WAS USED FOR ONE WEEK AND CAUSED DISCOMFORT AND BURNS TO THE TISSUE. THE PT FOLLOWED UP WITH HER DOCTOR AND USE OF THE PRODUCT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NO GAUZE PACKING STRIP/IODOFORM GAUZE, SPONGE, MEDICATED GEL JOHNSON & JOHNSON MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other