BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOSPORIN SCAR SHEETS

    MDR report key: 756875 · Received August 29, 2006

    Report

    Report Number
    2246407-2006-00005
    Event Type
    Other
    Date Received
    August 29, 2006
    Date of Event
    August 9, 2006
    Report Date
    August 29, 2006
    Manufacturer
    PFIZER, INC.
    Product Code
    MDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. IT CANNOT BE RULED OUT THAT THE PRODUCT MAY HAVE POSSIBLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A FEMALE CONSUMER APPLIED PART OF A NEOSPORIN SCAR SHEET (SILICONE) ONCE DAILY BEGINNING IN 2006, TO A SCAR ON HER FACE FROM RECENT MOLE REMOVAL SURGERY. TWO DAYS LATER, SHE HAD HIVES. SHE CONTINUED PRODUCT USE AND THIRTEEN DAYS LATER, THE HIVES WERE ALL OVER HER BODY. THE CONSUMER WENT TO THE ER THAT SAME DAY, WHERE SHE WAS TREATED WITH THREE UNSPECIFIED INJECTIONS AND BENADRYL (UNSPECIFIED). PRIOR TO THAT DAY, PRODUCT USE WAS DISCONTINUED AND THE EVENT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOSPORIN SCAR SHEETS ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA PFIZER, INC. UNK 22040-27

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other