BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NU-GAUZE PACKING STRIPS/IODOFORM

    MDR report key: 78961 · Received March 28, 1997

    Report

    Report Number
    1618732-1997-00047
    Event Type
    Injury
    Date Received
    March 28, 1997
    Date of Event
    September 1, 1996
    Report Date
    February 27, 1997
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC
    Product Code
    GEL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER OR SAMPLE PROVIDED FOR EVALUATION. THE MOST RECENT COMPLAINT TRENDS SHOW NO UNEXPLAINED UPWARD TRENDS FOR THIS PRODUCT RELATIVE TO THE REPORTED COMPLAINT CATEGORY. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    HAD ALLERGENIC TYPE REACTION TO IODOFORM PACKING STRIPS. EXACT SIZE (PRODUCT NUMBER ) NOT KNOWN. REQUIRED RETURN TRIP TO DOCTOR'S OFFICE FOR PACKING STRIP REMOVAL, WHICH SEEMED TO SLOWLY RESOLVE SYMPTOMS. NURSE STATED THAT THE PACKING STRIP WAS CAUSE OF REACTION. PACKING STRIP WAS REPLACED WITH PLAIN PACKING STRIPS, WITHOUT APPARENT RETURN OF OR INCREASE IN SYMPTOMS. PT RELATED THE SYMPTOMS TO BE STRANGE TASTE IN MOUTH AND TONGUE SWELLING. CALLED DR'S OFFICE AND WAS TOLD TO COME IN RIGHT AWAY. DID NOT REQUIRE HOSPITALIZATION OR ANY MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NU-GAUZE PACKING STRIPS/IODOFORM * GEL JOHNSON & JOHNSON MEDICAL, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R