BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O.B. ORIGINAL TAMPONS - APPLICATOR AND NON-APPLICATOR VERSIONS

    MDR report key: 14192639 · Received April 25, 2022

    Report

    Report Number
    2515444-2022-00016
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 25, 2022
    Manufacturer
    EDGEWELL PERSONAL CARE
    Product Code
    HEB
    PMA / PMN Number
    K974629
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IN PROCESS. NO INFORMATION ON THE EXACT PRODUCT OR LOT HAS BEEN SUPPLIED BY THE CONSUMER OTHER THAN A TAMPON WITH ¿OBO¿ WAS USED. PRELIMINARY RESULTS INDICATE QUALITY SYSTEMS WERE FUNCTIONING AS INTENDED. THE PRELIMINARY INVESTIGATIONS COMPLETED HAVE FOUND NO CORRELATION OR ASSOCIATION BETWEEN THE MANUFACTURING OF THE OB TAMPON PRODUCT AT (B)(4) PLANT AND THE REPORTED TSS EVENT.

    Description of Event or Problem · 0

    WHEN SHE TRIED TO REMOVE IT AFTER 2 HOURS THE STRING BROKE IN 2 PIECES [DEVICE BREAKAGE]. TOXIC SHOCK [TOXIC SHOCK SYNDROME]. THE TAMPON WAS REMOVED THE DOCTOR [FOREIGN BODY IN REPRODUCTIVE TRACT]. CASE NARRATIVE: ON (B)(6) 2022, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER, REGARDING AN ADOLESCENT FEMALE (SPECIFIC AGE WAS NOT REPORTED), WHO WAS BEING TREATED WITH O.B. ORIGINAL TAMPONS - APPLICATOR AND NON-APPLICATOR VERSIONS (TAMPON, MENSTRUAL, UNSCENTED). MEDICAL HISTORY INCLUDED SHE WAS EPILEPTIC. CONCOMITANT PRODUCTS WERE NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT STARTED USE OF O.B. ORIGINAL TAMPONS - APPLICATOR AND NON-APPLICATOR VERSIONS. ON (B)(6) 2022, AFTER INSERTING THE PRODUCT, THE CONSUMER EXPERIENCED THAT WHEN SHE TRIED TO REMOVE IT AFTER 2 HOURS THE STRING BROKE IN 2 PIECES AND WAS STILL STUCK INSIDE OF HER. SUBSEQUENTLY, SHE WENT TO THE ER (EMERGENCY ROOM) AND WAS TOLD THAT THERE WAS ONLY 1 DOCTOR ON DUTY, AND HE WAS IN SURGERY. SHE WAS TOLD SHE COULD PAY A FEE AND COME BACK TO SEE HIM ON (B)(6) 2022, OR IF SHE DID NOT PAY THE FEE, SHE COULD COME BACK AND SEE HIM ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT WENT BACK TO THE ER, UNSPECIFIED BLOOD TESTS WERE DRAWN, AND THE TAMPON WAS REMOVED BY THE DOCTOR. THE DOCTOR TOLD HER SHE HAD TOXIC SHOCK (PRESUMED TOXIC SHOCK SYNDROME) AND PRESCRIBED 2 UNSPECIFIED MEDICATIONS, WHICH WAS LATER CLARIFIED AS 1 UNSPECIFIED OINTMENT FOR AN INFECTION. THE DOCTORS DID NOT WANT TO GIVE HER ANY MEDICATIONS THAT MIGHT CAUSE HER TO HAVE A SEIZURE. SHE WAS ADVISED TO FINISH THE MEDICATION AND ONLY TO RETURN IF SHE HAD CONTINUED ISSUES. AS OF (B)(6) 2022, THE TOXIC SHOCK WAS ONGOING, AND THE STATUS OF PRODUCT USE WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980572 O.B. ORIGINAL TAMPONS - APPLICATOR AND NON-APPLICATOR VERSIONS TAMPON, MENSTRUAL, UNSCENTED HEB EDGEWELL PERSONAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention