BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASHAPE

    MDR report key: 5678414 · Received May 25, 2016

    Report

    Report Number
    3004772125-2016-00001
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    March 18, 2016
    Report Date
    May 10, 2016
    Manufacturer
    SYNERON MEDICAL LTD.
    Product Code
    OHV
    PMA / PMN Number
    K141708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE ROOT CAUSE IS USER ERROR - OFF LABEL TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016 SYNERON RA WAS MADE AWARE OF CUSTOMER COMPLAINT ON POSSIBLE INJURY FOLLOWING TREATMENT WITH VDF TRANSDUCER AND ULTRASHAPE SYSTEM AT THE (B)(6). ON (B)(6), A FEMALE PATIENT UNDERWENT TREATMENT WITH THE VDF TRANSDUCER ON THE INNER THIGH AND SUSTAINED A BLISTER ON THE TREATED AREA ONE DAY AFTER THE TREATMENT. ACCORDING TO THE CUSTOMER, THERE WERE NO COMPLAINTS DURING THE TREATMENT AND THEY WERE MADE AWARE OF THE BLISTER ONLY WHEN THE PATIENT CAME BACK FOR HER SECOND TREATMENT ON (B)(6). PHOTO OF THE PATIENT TAKEN ON (B)(6) SHOWS THE INJURY TO BE MODERATE IN SEVERITY. ACCORDING TO (B)(6), THE INJURY IS A RESULT OF TREATMENT WITH THE LARGE VDF TRANSDUCER ON THE INNER THIGH. VERY IMPORTANT, THE VDF TRANSDUCER IS FDA CLEARED FOR USE FOR THE ABDOMEN AREA ONLY. ACCORDINGLY, THIS IS AN OFF LABEL USE OF THE VDF TRANSDUCER THAT IS NOT FOLLOWING THE RECOMMENDED TREATMENT GUIDELINES AS STATED IN THE USER MANUAL AND THE CLINIC WAS NOT INSTRUCTED TO PERFORM THIS TYPE OF TREATMENT DURING THE CLINICAL TRAINING. THE TRANSDUCER WAS REPLACED (TO BE ON THE SAFE SIDE). THE SYSTEM WAS TESTED AND FOUND WITHIN SPECIFICATIONS. ON (B)(6) THE CUSTOMER REPORTED THAT SUPPOSEDLY THEY HAD ADDITIONAL BURN INCIDENTS, HOWEVER NO ADDITIONAL/SPECIFIC INFORMATION WAS PROVIDED BY THE SITE. UPON VISIT OF THE SITE BY (B)(6) NO ADDITIONAL COMPLAINTS WERE REPORTED. HOWEVER, GIVEN THAT THIS INCIDENCE IS A RESULTS OF A USER ERROR RETRAINING OF THE SITE WILL BE SCHEDULED SHORTLY TO REEMPHASIZE THE CLINICAL INSTRUCTIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334551 ULTRASHAPE ULTRASHAPE OHV SYNERON MEDICAL LTD. FG71051US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other