BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIVATYTE

    MDR report key: 11613194 · Received April 2, 2021

    Report

    Report Number
    MW5100544
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 1, 2021
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD DIVA TYTE VAGINAL LASER TREATMENT DONE 2 TIMES 6 WEEKS APART STARTING 4 MONTHS AGO. I'M EXPERIENCING LOSS OF SENSITIVITY, SCARRING, PAIN, AND POSSIBLE BURNS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508993 DIVATYTE POWERED LASER SURGICAL INSTRUMENT GEX SCITON, INC.
    508994 DIVATYTE POWERED LASER SURGICAL INSTRUMENT GEX SCITON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR