BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN

    MDR report key: 3733074 · Received March 27, 2014

    Report

    Report Number
    1219109-2014-00003
    Event Type
    Injury
    Date Received
    March 27, 2014
    Report Date
    March 12, 2014
    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

    PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER THEREFORE UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. PROCTER AND 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 MFR 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. REASON THAT THE DEVICE HAS NOT BEEN EVAL BY THE MFR: (B)(4).

    Description of Event or Problem · 1

    TOXIC SHOCK SYNDROME [TOXIC SHOCK SYNDROME]. MIGRAINE [MIGRAINE]. CASE DESCRIPTION: A RELATIVE REPORTED THAT HER DAUGHTER, AGE UNSPECIFIED, USED TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK AND REPORTED THE FOLLOWING: HAD TOXIC SHOCK SYNDROME AND SHE HAS A MIGRAINE FOR ONE MONTH NOW. THE CONSUMER WAS ADMITTED TO THE HOSPITAL FOR 5 DAYS. THE CASE OUTCOME WAS RECOVERED/RESOLVED WITH SEQUEL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179639 TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN NONE HEB TAMBRANDS MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O