BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFOUND SYSTEM (FORMERLY KNOWN AS MIRATONE SYSTEM)

    MDR report key: 5889640 · Received August 19, 2016

    Report

    Report Number
    3004772125-2016-00020
    Event Type
    Injury
    Date Received
    August 19, 2016
    Date of Event
    May 26, 2016
    Manufacturer
    SYNERON MEDICAL LTD.
    Product Code
    GEI
    PMA / PMN Number
    K082391
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    [THE APPLICATOR ITSELF IS RE-USED, BUT THE PATIENT-CONTACTING COMPONENT OF THE SYSTEM (WITH WHICH IT'S USED) IS SINGLE USE.] THE PROFOUND DERMAL HANDPIECE (S/N: (B)(4) WAS REPLACED AND SENT FOR EVALUATION. INITIAL EVALUATION SHOWED THAT THE HANDPIECE OVER DEPLOYS THE NEEDLES. THE HANDPIECES WAS SENT FOR FURTHER EVALUATION IN SYNERON HEADQUARTERS (INVESTIGATION STILL IN PROCESS). TREATMENT INSTRUCTIONS RECOMMEND THAT INSERTION DENSITY WOULD BE 3-4MM. IN THIS PATIENT, HIGHER DENSITY OF INSERTION WAS APPLIED (ALMOST DOUBLE AMOUNT; ALTHOUGH THE SITE WAS ALREADY RETRAINED PRIOR TO THIS OCCASION REGARDING THE CORRECT NUMBER OF INSERTIONS); HIGHER DENSITY OF TREATMENT COULD POTENTIALLY RESULT IN SCARING. ADDITIONALLY, THE HANDPIECE USED DURING THE TREATMENT DEMONSTRATES OVER-DEPLOYMENT OF THE NEEDLES, OVER DEPLOYMENT OF THE NEEDLES CAN POTENTIALLY RESULT IN BENT NEEDLES, WHICH COULD POTENTIALLY RESULT IN IMPROPER NEEDLES INSERTION. HOWEVER, IN THIS CASE WE COULD NOT DETERMINE WHETHER THE SCARING IS THE RESULT OF IMPROPER NEEDLE INSERTION (DUE TO THE BENT NEEDLES) OR DUE TO HIGHER DENSITY OF INSERTIONS.

    Description of Event or Problem · 1

    ON JULY 20, 2016 SYNERON RA WAS MADE AWARE OF A CUSTOMER COMPLAINT REGARDING A POSSIBLE INJURY FOLLOWING TREATMENT WITH PROFOUND SYSTEM USING THE DERMAL HANDPIECE, OCCURRING AT DR. (B)(6) PRACTICE,(B)(6) USA. A FEMALE PATIENT ((B)(6), SKIN TYPE II), WAS TREATED ON THE FACE AND SUBMENTAL AREAS AND REPORTED SUSTAINED SCARS ON THE SUBMENTAL AREA (NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED). ACCORDING TO THE PROVIDED INFORMATION THE PATIENT WAS NOT TANNED PRE OR POST TREATMENT; MEDICATIONS USED BY THE PATIENT: VALIUM, DURICEF, & VALTREX; TREATMENT SETTING USED WERE: TEMP - 67DEG., PULSE DURATION -3 SEC, INSERTIONS DENSITY -2MM, PASSES-1. DURING THE TREATMENT, THE PATIENT DID NOT COMPLAIN OF PAIN OR DISCOMFORT. IMMEDIATELY POST THE TREATMENT BUMPS (DEMARCATED SWELLING) WERE OBSERVED ON THE SUBMENTAL AREA. ONE DAY POST TREATMENT BUMPS WERE STILL OBSERVED ALONG THE SUBMENTAL AREA. ONE WEEK POST TREATMENT SCARING ALONG SUBMENTAL REGION WERE OBSERVED IN PATTERN OF THE DEPLOYED NEEDLES. THE SITE REPORTED THEY USED 5 CARTRIDGES DURING THE TREATMENT (USUALLY ONE TO TWO CARTRIDGES ARE USED). TWO MONTHS' POST TREATMENT THE SITE REPORTED THE SCARS PERSISTED WITH SLIGHT IMPROVEMENT (NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539798 PROFOUND SYSTEM (FORMERLY KNOWN AS MIRATONE SYSTEM) ELECTROSURGICAL CUTTING AND COAGULATION DEVICE GEI SYNERON MEDICAL LTD. FG70513US

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR