BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L.TAMPONSORGCOTTONCOMPAK

    MDR report key: 15251209 · Received August 18, 2022

    Report

    Report Number
    1216894-2022-00029
    Event Type
    Injury
    Date Received
    August 18, 2022
    Report Date
    September 16, 2022
    Manufacturer
    ONTEX HYGIENEARTIKEL GMBH
    Product Code
    HEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TAMPONS BREAK OFF INSIDE OF ME AND I HAD TO FISH THEM OUT VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] . TAMPONS BREAK OFF INSIDE OF ME [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT TWO TAMPONS BROKE OFF INSIDE OF HER AND SHE HAD TO FISH THEM OUT. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    TAMPONS BREAK OFF INSIDE OF ME AND I HAD TO FISH THEM OUT- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS BREAK OFF INSIDE OF ME [DEVICE BREAKAGE]. CAUSE WAS TRACED TO DESIGN [PRODUCT DESIGN ISSUE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT TWO TAMPONS BROKE OFF INSIDE OF HER AND SHE HAD TO FISH THEM OUT. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025159 L.TAMPONSORGCOTTONCOMPAK TAMPON, MENSTRUAL, UNSCENTED - HEB HEB ONTEX HYGIENEARTIKEL GMBH 1839226 23:46

    Patients

    Seq Age Sex Outcome Treatment
    1 Female