BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1 APPLIC

    MDR report key: 2033498 · Received March 24, 2011

    Report

    Report Number
    1219109-2011-00004
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 26, 2011
    Manufacturer
    TAMBRANDS MANUFACTURING, INC.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OR PRODUCT SAMPLES WERE NOT PROVIDED BY THE REPORTER. THEREFORE, UNABLE TO PROCEED WITH LOT CHECK/BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. PROCTER & GAMBLE (P&G) IS SUBMITTING THIS REPORT ONLY BECAUSE IT BELIEVES AN EVENT THAT MEETS THE REQUIREMENTS OF 21 CFR PART 803 MAY HAVE OCCURRED. THIS DOES NOT MEAN THAT P&G BELIEVES THE DEVICE MANUFACTURED BY P&G MAY BE DEFECTIVE OR HAS MALFUNCTIONED, OR THAT A TAMPAX PRODUCT WAS IN FACT ASSOCIATED WITH AN ACTUAL CONSUMER INJURY. CONSEQUENTLY, THIS REPORT MUST NOT BE CONSTRUED AS AN ADMISSION OF ANY KIND BY P&G.

    Description of Event or Problem · 1

    PAIN IN VAGINA [VULVOVAGINAL PAIN]. CASE DESCRIPTION: A CONSUMER REPORTED THAT HER DAUGHTER, AGE UNSPECIFIED, USED THE TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK FROM A VALUE PACK, 1 APPLICATION EVERY 4 HOURS FOR 4 DAYS, AND WAS SENT TO THE HOSPITAL WITH SERIOUS PAIN IN HER VAGINA. HER DAUGHTER HAS BEEN IN THE HOSPITAL FOR ALMOST 2 WHOLE DAYS NOW. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1 APPLIC NONE HEB TAMBRANDS MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O