BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPON MENSTRUAL UNSCENTED

    MDR report key: 20664430 · Received November 12, 2024

    Report

    Report Number
    3014829931-2024-00003
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ALBAAD MASSUOT YITZHAK LTD
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER DID NOT REPORT TYPE SUPER ABSORBENCY TAMPON LOT NUMBER AND NO LONGER HAS THE PACKAGE; THEREFORE, THE HONEY POT COMPANY'S INVESTIGATION EFFORTS ARE LIMITED. IF FURTHER PRODUCT INFORMATION BECOMES AVAILABLE THAT ENABLES THE HONEY POT COMPANY TO INVESTIGATE WITH THE MANUFACTURER FURTHER AND INFORMATION FROM THE INVESTIGATION IS ATTRIBUTABLE TO THIS COMPLAINT, THEN FORM 3500A WILL BE UPDATED WITH THAT INFORMATION.

    Description of Event or Problem · 0

    ON 29-OCT-2024, THIS REPORT WAS RECEIVED FROM A CONSUMER VIA EMAIL REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) FROM THE UNITED STATES. ON AN UNSPECIFIED DATE THE CONSUMER INSERTED A THE HONEY POT TAMPON. AFTER INSERTION, WHEN THE CONSUMER PULLED THE PLASTIC APPLICATOR OUT, THE TOP WAS BROKEN OFF. SHE NOTED THAT THERE WAS A PIECE OF PLASTIC RETAINED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539937 TAMPON MENSTRUAL UNSCENTED TAMPON, MENSTRUAL, UNSCENTED HEB ALBAAD MASSUOT YITZHAK LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other