BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHE

    MDR report key: 7116423 · Received December 14, 2017

    Report

    Report Number
    3007740671-2017-00006
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 12, 2017
    Manufacturer
    TOSAMA D.O.O.
    Product Code
    HEB
    PMA / PMN Number
    K151170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION FROM THIS EVENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    CONSUMER STATED THAT TAMPON COMPONENTS SEPARATED AT REMOVAL, MOST PROBABLY AFTER TAMPON UNRAVELLING. PART OF THE TAMPON REMAINED AS A CONSEQUENCE OF COMPONENTS SEPARATION. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897092 SHE UNSCENTED MENSTRUAL TAMPON HEB TOSAMA D.O.O. 1610654

    Patients

    Seq Age Sex Outcome Treatment
    1