BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN

    MDR report key: 17441471 · Received August 2, 2023

    Report

    Report Number
    1219109-2023-00247
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Report Date
    August 1, 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

    HAVE HAD THE SAME TAMPON IN FOR A FEW DAYS...CAN'T SEE THE STRING- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. SAME TAMPON IN FOR A FEW DAYS [DEVICE USE ISSUE]. CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT SHE CAN'T SEE THE STRING TO REMOVE THE TAMPON. NO SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740700 TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN TAMPON, MENSTRUAL, UNSCENTED - HEB HEB TAMBRANDS MANUFACTURING, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female