BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOSPORIN SCAR SOLUTION

    MDR report key: 785780 · Received November 21, 2006

    Report

    Report Number
    2246407-2006-00011
    Event Type
    Death
    Date Received
    November 21, 2006
    Date of Event
    January 1, 2006
    Report Date
    November 8, 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

    ONE OF TWO CASES REPORTED BY THE SAME REPORTER. A PREGNANT FEMALE CONSUMER BEGAN USING ONE NEOSPORIN SCAR SOLUTION SHEET (SILICONE) EVERY 3 TO 4 DAYS IN 2006 (EXACT DATE UNSPECIFIED) FOR SCAR REDUCTION. AT TIME OF REPORTING, THE OUTCOME OF THE PREGNANCY AND PRODUCT USE WERE UNKNOWN. FOLLOW-UP INFORMATION RECEIVED BY PFIZER ON NOV 08, 2006 HAS UPGRADED THIS CASE TO SERIOUS. THE CONSUMER REPORTED THAT DURING A ROUTINE PREGNANCY CHECK-UP IN 2006 (EXACT DATE UNSPECIFIED), SHE WAS INFORMED THAT THE FETUS PASSED AWAY IN UTERO. THE CONSUMER STATED "THE FETUS NO LONGER HAD A HEARTBEAT". THE CONSUMER FURTHER STATED THE DOCTOR WAS UNABLE TO DETERMINE THE CAUSE OF DEATH DUE TO THE LENGTH OF TIME THAT HAD PASSED SINCE THE INTRA-UTERINE DEATH. THE CONSUMER REQUESTED NO FURTHER CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOSPORIN SCAR SOLUTION ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA PFIZER INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Death