BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPSURE

    MDR report key: 6175264 · Received December 15, 2016

    Report

    Report Number
    1222993-2016-00060
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 3, 2016
    Report Date
    December 13, 2016
    Manufacturer
    CYNOSURE INC
    Product Code
    PKT
    PMA / PMN Number
    K150724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS ADMITTED TO A HOSPITAL FOR 3 DAYS, WHERE IT RECEIVED AN ENDOSCOPY PROCEDURE INDICATING IT HAD BROKEN CAPILLARIES. PHYSICIAN STATED HEAT FROM THE LASER PROCEDURE CAUSED THE BROKEN CAPILLARIES. HOWEVER, THE DEVICE'S MECHANISM OF ACTION DOES NOT PENETRATE BEYOND THE SUBCUTANEOUS FAT LAYER SO THE IMPACT OF THE TREATMENT WOULD NOT CONTRIBUTE TO CAPILLARY DAMAGE. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED. PATIENT HAS SINCE HEALED FROM THIS INCIDENT. THIS INCIDENT IS REPORTABLE SINCE THE PATIENT HAD MEDICAL INTERVENTION AT THE HOSPITAL.

    Description of Event or Problem · 1

    PATIENT DEVELOPED EXPERIENCED VOMITING / DIARRHEA (BLOODY) FOLLOWING A LASER PROCEDURE ON THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829772 SCULPSURE SCULPSURE PKT CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization