BEUDAMED
    FDA Adverse Event Summary report: N

    TRUSCULPT

    MDR report key: 4178532 · Received October 10, 2014

    Report

    Report Number
    2954354-2014-00005
    Date Received
    October 10, 2014
    Date of Event
    December 2, 2013
    Report Date
    January 14, 2014
    Manufacturer
    CUTERA, INC.
    Product Code
    PBX
    PMA / PMN Number
    K122389
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014: THIS IS CUTERA'S RESPONSE REPORT TO MDR REPORT (B)(4) SUBMITTED TO THE FDA MEDWATCH PROGRAM ON 06/04/2014 BY THE PT AND RECEIVED AT CUTERA SEPTEMBER 2014. THIS REPORT IS THE SAME EVENT AS (B)(4) SUBMITTED TO THE FDA MEDWATCH PROGRAM ON 04/08/2014 BY THE DEVICE OWNER/OPERATOR AND RECEIVED AT CUTERA MAY 2014. CUTERA SENT THE FOLLOWING RESPONSE IN MFR REPORT 2954354-2014-00004. CUTERA IS NOT AWARE OF ANY NEW INFO THAT REASONABLY SUGGEST THAT A CUTERA DEVICE CAUSED OR CONTRIBUTED TO A SEVERE INJURY. TO DATE, CUTERA HAS NOT RECEIVED ANY REQUESTED MEDICAL EVALUATIONS FROM THE PT OR THE DEVICE OWNER/OPERATOR. THE FOLLOWING INFO IS KNOWN BY CUTERA ABOUT THIS ALLEGED EVENT: THE PT HAD A TRUSCULPT TREATMENT TO THE ABDOMEN AND POSTERIOR THIGHS ON (B)(6) 2013. THE PT RETURNED FOR HER SECOND TRUSCULPT TREATMENT ON (B)(6) 2014. THE DEVICE OWNER/OPERATOR CONTACTED CUTERA 02/14/2014 WITH CLINICAL COMPLAINT OF "GENERALIZED SWELLING" AND WEIGHT GAIN OF "8 LBS." TENDERNESS IN THE TREATMENT AREA AND "NODULES" THAT RESOLVED. THE DEVICE OWNER/OPERATOR SENT 3 PHOTOS THAT ARE DATED (B)(6) 2014. THERE IS NO EVIDENCE OF PATIENT INJURY OR IMPAIRMENT IN THE PHOTOS. THE PATIENT'S WEIGHT WAS NOT DOCUMENTED IN THE PATIENT MEDICAL RECORD BEFORE OR AFTER THE TRUSCULPT TREATMENTS AND AT THE TIME THE PATIENT COMPLAINED OF "WEIGHT GAIN". THE PATIENT HAS NOT BEEN EVALUATED BY A PHYSICIAN. "SWELLING, BRUISING, NODULES AND PAIN" ARE KNOWN SHORT TERM SIDE EFFECTS OF THE PROCEDURE AND ARE LISTED IN THE DEVICE LABELING. "WEIGHT GAIN" IS NOT A KNOWN SIDE EFFECT ASSOCIATED WITH THE PROCEDURE. THE DEVICE OWNER/OPERATOR HAS CONTACTED CUTERA ON NUMEROUS OCCASIONS TO REPORT CLINICAL COMPLAINTS OF "PATIENT INJURY" AND HAS DEMANDED A REFUND FOR THE EQUIPMENT PURCHASED IN ORDER TO BUY A DIFFERENT TECHNOLOGY. DURING EACH CONTACT WITH THE DEVICE OWNER/OPERATOR CUTERA HAS REQUESTED ALL SUPPORTING MEDICAL OR SCIENTIFIC INFORMATION THAT REASONABLY SUGGESTS THAT A CUTERA DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS PATIENT INJURY/IMPAIRMENT. CUTERA HAS REPEATEDLY REQUESTED COPIES OF PHYSICIAN EVALUATIONS AND DOCUMENTATION OF THE PATIENT MEDICAL CARE AND HAVE NOT BEEN PROVIDED WITH ANY MEDICAL DOCUMENTS THAT CONFIRM THE PATIENT HAS RECEIVED PROFESSIONAL MEDICAL INTERVENTION FOR A SERIOUS PATIENT INJURY OR IMPAIRMENT. THERE ARE NO SERVICE COMPLAINTS ASSOCIATED WITH THE DEVICE AND THE DEVICE HAS NOT BEEN RETURNED TO CUTERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643106 TRUSCULPT MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT PBX CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR