BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLFINA

    MDR report key: 6429743 · Received March 23, 2017

    Report

    Report Number
    3006560326-2017-00006
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    August 8, 2016
    Report Date
    March 16, 2017
    Manufacturer
    ULTHERA, INC
    Product Code
    OUP
    PMA / PMN Number
    K161885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ULTHERA MEDICAL DIRECTOR DISCUSSED USE OF COMPRESSIVE GARMENTS, MASSAGE, MUD-WRAPS TO ABSORB TISSUE FLUID (FOR THOSE THAT HAVE ACCESS TO THIS MODALITY) COULD BE APPLIED AS THE SOLUTION FOR PROBLEM MANAGEMENT. HOWEVER, THE PATIENT IS NOT RETURNING FOR FURTHER FOLLOW-UP. DR. (B)(6) WILL SEND THE PATIENT A LETTER ASKING HER TO RETURN AND WILL ITEMIZE PROPOSED TREATMENTS.  THE DEVICE WAS UNABLE TO BE INVESTIGATED AS IT'S A SINGLE USE DISPOSABLE. THE PRACTICE DID NOT RECORD THE LOT NUMBER, THEREFORE UNAVAILABLE FOR THIS REPORT (AS WELL AS THE UDI). IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. DEVICE DISPOSED, SINGLE USE.

    Description of Event or Problem · 1

    ULTHERA, INC. RECEIVED A REPORT ON 2/23/2017 FROM A HEALTH CARE PROVIDER (HCP) STATING THAT A PATIENT CURRENTLY UNDER HER CARE FOR ENDERMOLOGIE TREATMENT WAS CONCERNED WITH THE RESULTS FROM THE PATIENT'S CELLFINA TREATMENT RECEIVED ON (B)(6) 2016 FROM ANOTHER PRACTICE. ULTHERA, INC. CONTACTED THE ORIGINAL HCP THAT TREATED THE PATIENT ON (B)(6) 2016 AND RECEIVED INFORMATION THAT THE CELLFINA TREATMENT FOR BUTTOCKS, POSTERIOR, LATERAL, AND ANTERIOR THIGHS WENT SMOOTHLY AND WITHOUT EVENT. THE PATIENT SAW THE ORIGINAL HCP FOR A FOLLOW-UP VISIT ON (B)(6) 2016 AND DEMONSTRATED GOOD RESULT WITH NO WARNING SIGNS. A SECOND FOLLOW-UP VISIT WAS RECOMMENDED IN (B)(6) 2016, HOWEVER THE PATIENT RESCHEDULED TO (B)(6) 2016 WHEN THE PATIENT PRESENTED WITH SOME LOCALIZED THIGHS DEFORMITIES. DURING THE (B)(6) FOLLOW-UP VISIT, THE PATIENT STATED THAT SOMETIME BETWEEN (B)(6), SHE HAD RECEIVED ENDERMOLOGIE TREATMENT WITH A DIFFERENT HCP (THE REPORTER). LATER, THE PATIENT RETRACTED THAT SHE WAS TREATED WITH ENDERMOLOGIE DURING THAT TIME. BASED ON REVIEW OF THE ORIGINAL CELLFINA TREATMENT RECORDS, INITIAL FOLLOW-UP RESULTS AND CURRENT PHOTOS, IT IS SUSPECTED THAT THE PATIENT DID RECEIVE ENDERMOLOGIE IN THE AREAS SHE ALSO RECEIVED CELLFINA TREATMENT. THE ENDERMOLOGIE TREATMENT GIVEN TO THE SAME AREAS THE CELLFINA TREATMENT COULD POTENTIALLY AGGRAVATE THE INITIAL SUBCISSIONS FROM THE CELLFINA TREATMENT CAUSING THE LOCALIZED SWELLINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209714 CELLFINA CELLFINA STERILE DISPOSABLE KIT OUP ULTHERA, INC CK1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R