BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIXEL CO2

    MDR report key: 8940057 · Received August 28, 2019

    Report

    Report Number
    3004167969-2019-00011
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    August 30, 2017
    Report Date
    August 2, 2019
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K103501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    ALMA INC. (IMPORTER) HAS INSPECTED THE DEVICE AND FOUND THE UNIT TO BE WORKING WITHIN THE MANUFACTURER'S SPECIFICATIONS. DEVICE MANUFACTURE DATE: 12/03/2012, APPLICATOR MANUFACTURE DATE: 12/21/2014. APPROXIMATE AGE OF DEVICE IS 6.5 YEARS, APPROXIMATE AGE OF APPLICATOR IS 4.5 YEARS. ALMA LTD. CLINICAL DEPARTEMENT REVIEWED THE LIMITED INFORMATION, MOST LIKELY ROOT CAUSE IS PARAMETER SETTING DEVIATION FROM MANUFACTURER PROTOCOL. IN ABSENCE OF ANY MEDICAL RECORDS, PHOTOS OR MEASUREMENTS, THE ALLEGED INCIDENT CANNOT BE SUBSTANTIATED. GIVEN THE LACK OF DETAILS, ALMA IS SUBMITTING THIS REPORT TO THE FDA IN GOOD FAITH EFFORTS. SHOULD ANY INFORMATION BECOME AVAILABLE, ALMA WILL SUBMIT SUPPLEMENTAL REPORT WITHIN THE FDA PUBLISHED TIMELINES. WHEN OUTPUTTING 3500A TO PDF FORM THERE IS A PROBLEM WITH DATE DISPLAY. DUE TO UNKNOWN DISPLAY DATE FORMAT AFTER PACKAGE FILES, PLEASE FIND THE DATES DETAILED BELOW (MM/DD/YYYY): AGE: (B)(6). DATE OF EVENT: (B)(6) 2017. DATE OF REPORT: 08/02/2019. DATE USER FACILITY OR IMPORTER BECAME AWARE OF EVENT: (B)(4) 2019. DATE RECEIVED BY MANUFACTURER: 08/02/2019. DEVICE MANUFACTURE DATE: 12/03/2012.

    Description of Event or Problem · 1

    IN 2017, THE PATIENT UNDERWENT THREE VAGINAL PROCEDURES WITH THE SUSPECTED DEVICE. PER THE FACILITY, THE PATIENT RETURNED AFTER A YEAR FOR ANOTHER TREATMENT AS SHE NOTED IMPROVEMENT. THE PRACTIONER PERFORMED BIMANUAL EXAM AND NOTED SHORTENED VAGINAL CANAL AND SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736609 PIXEL CO2 MEDICAL LASER GEX ALMA LASERS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other