BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAMPAX PEARL TAMPON, UNSCENTED, ABSORBANCY UNKNOWN (NA) TAMPON 1APPLIC

    MDR report key: 2933206 · Received January 11, 2013

    Report

    Report Number
    1219109-2013-00001
    Event Type
    Other
    Date Received
    January 11, 2013
    Report Date
    December 13, 2012
    Manufacturer
    TAMBRANDS MANUFACTURING, INC.
    Product Code
    HEB
    PMA / PMN Number
    K011996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER; UNABLE TO PROCEED WITH PRODUCT INVESTIGATION, CONSUMER HAD DISCARDED THE PRODUCT.

    Description of Event or Problem · 1

    TORN HYMEN [VAGINAL LACERATION]. UPON INSERTING TAMPON, SAW A LOT OF BLOOD WAS COMING OUT [VAGINAL HAEMORRHAGE]. COULD NOT PULL TAMPON OUT [DEVICE DIFFICULT TO USE]. CASE DESCRIPTION: A RELATIVE REPORTED THAT THEIR DAUGHTER, A FEMALE AGE UNKNOWN, USED TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN AND REPORTED THE FOLLOWING: VAGINAL BLEEDING, TORN HYMEN. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: PRIVATE SURGERY TO HAVE HYMEN COMPLETELY REMOVED. THE CASE OUTCOME WAS UNKNOWN. PAST MEDICAL HISTORY INCLUDED: HIST DRUG/PREV EXP-TAMPAX PRODUCTS, SMALL YELLOW TAMPON. NO FURTHER INFO WAS PROVIDED. ON (B)(4) 2012 - CR CALL TO CONSUMER'S MOTHER: THE MOTHER REPORTED THE CONSUMER IS (B)(6) OF AGE AND HAS BEEN USING TAMPONS FOR ABOUT SIX MONTHS, UNKNOWN BRAND. THE MOTHER REPORTED THAT UPON INSERTING, SAW A LOT OF BLOOD WAS COMING OUT AND CONSUMER COULD NOT PULL THE TAMPON OUT. THE MOTHER REPORTED CALLING THE EMERGENCY CLINIC AND CONSUMER HAD AN OPERATION TO COMPLETELY REMOVE THE ENTIRE HYMEN. NO FURTHER INFO WAS PROVIDED. ON (B)(4) 2012 - CR CALL TO CONSUMER: THE DAUGHTER REPORTED SHE USED A TAMPAX PEARL TAMPON AND HAD PREVIOUSLY USED CARDBOARD APPLICATOR TAMPONS, NO BRAND NAME GIVEN. SHE REPORTED THE TAMPON WAS VERY DIFFICULT TO GET OUT. DAUGHTER GAVE THE REMAINING BOX OF PRODUCT TO A FRIEND. CONSUMER REPORTED BEING UNSURE IF EVENTS WERE RELATED TO HER BEING A DANCER WHO DOES THE SPLITS ALL THE TIME. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19181 TAMPAX PEARL TAMPON, UNSCENTED, ABSORBANCY UNKNOWN (NA) TAMPON 1APPLIC NONE HEB TAMBRANDS MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other