BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMWAVE WAA

    MDR report key: 11784725 · Received May 6, 2021

    Report

    Report Number
    3010676138-2021-00086
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 6, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020150
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STIMWAVE INITIATED (B)(4) TO RETURN THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES OR ISSUES WHICH COULD HAVE LED TO THE FAILURE OF THE DEVICE WERE IDENTIFIED. ON MAY 4, 2021, STIMWAVE INVESTIGATED THE DEVICE FOR THE ALLEGED SHOCK. THE DEVICE WAS VERIFIED ON AN ENGINEERING BENCH AND TESTED IN THE FACTORY WAA TEST. INVESTIGATION OF THE DEVICE WAS UNABLE TO REPLICATE THE ALLEGED ISSUE, AND NO NON-CONFORMANCES WERE FOUND. THERE IS NO ROOT CAUSE, AS NO PROBLEM WAS FOUND.

    Description of Event or Problem · 1

    ON APRIL 21, 2021, STIMWAVE RECEIVED A COMPLAINT IN WHICH THE PATIENT HAD REPORTED TO THE CLINICAL REPRESENTATIVE EXPERIENCING A SHOCK WHILE USING SPECIFIC PROGRAM SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678280 STIMWAVE WAA WEARABLE ANTENNA ASSEMBLY GZF STIMWAVE TECHNOLOGIES INC. PDBT-915-2K 00383-S 00818225020150

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O| R