BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAXTAMPONSPEARLFULLSIZEULTRA

    MDR report key: 18318332 · Received December 13, 2023

    Report

    Report Number
    1219109-2023-00412
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Report Date
    November 22, 2023
    Manufacturer
    TAMBRANDS MANUFACTURING, INC
    Product Code
    HEB
    PMA / PMN Number
    K081555
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS INSUFFICIENT INFORMATION TO PERFORM AN INVESTIGATION.

    Description of Event or Problem · 0

    PIECES OF TAMPONS GET STUCK INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] COME APART INSIDE OF ME WHILE TRYING TO REMOVE IT [COMPLICATION OF DEVICE REMOVAL] COME APART INSIDE OF ME- TAMPON [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON CAME APART INSIDE OF HER DURING REMOVAL. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695269 TAMPAXTAMPONSPEARLFULLSIZEULTRA TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female