BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMTEX REGULAR ABSORBENCY ROUNDED TIP TAMPONS

    MDR report key: 242084 · Received September 21, 1999

    Report

    Report Number
    2529605-1999-00003
    Event Type
    Other
    Date Received
    September 21, 1999
    Date of Event
    August 24, 1999
    Report Date
    September 21, 1999
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PRIOR TO SEEING A PHYSICIAN, THE TAMPON USER REPORTED TO THE QA SUPERVISOR THAT SHE EXPERIENCED PAIN WHEN URINATING AFTER USING THE SECOND TAMPON. SHE FURTHER INDICATED THAT THIS WAS DURING HER FIRST PERIOD AFTER HAVING A BABY AND THAT SHE HAD NEVER USED TAMPONS BEFORE. THE QA SUPERVISOR ADVISED HER TO SEE A DOCTOR. RATHER THAN WAIT UNTIL HER REGULAR DOCTOR COULD SEE HER, THE USER WENT TO AN ER WHERE URINALYSIS, BLOOD TEST, AND PELVIC EXAMINATION WERE CONDUCTED. THE USER REPORTED THAT THE ER DOCTOR TOLD THE USER THAT SHE HAS A CERVICAL INFLAMMATION AND PRESCRIBED PAIN MEDICATION AND SITZ BATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMTEX REGULAR ABSORBENCY ROUNDED TIP TAMPONS VAGINAL TAMPONS HEB FIRST QUALITY HYGIENIC, INC. ROUNDED TIP TAMPON 99ERC06E

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention