BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C+B PELO SYSTEM

    MDR report key: 7598141 · Received June 13, 2018

    Report

    Report Number
    3011423170-2018-00057
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 9, 2018
    Report Date
    May 16, 2018
    Manufacturer
    GME GERMAN MEDICAL ENGINEERING
    Product Code
    ONG
    PMA / PMN Number
    K120433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT#: WAS SUBMITTED IN ERROR. SOLTA MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE C+B PELO SYSTEM. SOLTA MEDICAL HAS NOTIFIED THE LEGAL MANUFACTURER, GME, OF THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE PATIENT HAD MULTIPLE SITES TREATED; UPPER LIP, CHIN, AXILLA AND THE FRONT AND BACK OF THE LOWER LEGS. THE LOWER LEGS WERE TREATED LAST. THE TECHNICIAN APPLIED ALOE TO THE PATIENTS LOWER LEGS AFTERWARDS DUE TO DISCOMFORT. THE PATIENT STATES THAT LATER IN THE EVENING, OR IT COULD HAVE BEEN FIRST THING IN THE MORNING, RAISED RED WELTS IN A POLKA DOT FORMATION APPEARED. THE DOCTOR PUT THE PATIENT ON BENADRYL AND 1% HYDROCORTISONE CREAM. THE PATIENT IS IMPROVING AND PERMANENT DAMAGE OR SCARRING IS NOT LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441338 C+B PELO SYSTEM POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM ONG GME GERMAN MEDICAL ENGINEERING 1042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other