BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYTITE

    MDR report key: 16395050 · Received February 17, 2023

    Report

    Report Number
    3010511300-2023-00067
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    December 2, 2021
    Report Date
    February 17, 2023
    Manufacturer
    INMODE LTD
    Product Code
    GEI
    UDI-DI
    17290016633211
    PMA / PMN Number
    K182325
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    USER ERROR: EXCESSIVE QUANTITY OF ENERGY WAS DELIVERED (25.2KJ) IN RELATIVELY SMALL AREA (SUPRAPUBIC AREA- MONS). THIS ENERGY SURPLUS, TRANSFORMING INTO HEAT, WAS IRRADIATED WITH A RETARDING EFFECT TOWARDS THE DERMAL TISSUE, CAUSING BURNS AND TISSUE NECROSIS. A SUBSEQUENT SECONDARY INFECTION CANNOT BE RULED OUT. SUMMARY OF RELATED INVESTIGATIONS AN EXCESSIVE AMOUNT OF ENERGY GENERATED AN ACCUMULATED SURPLUS OF HEAT WHICH EVOLVED INTO TRANS SKIN BURN WITH NECROTIC OUTCOME AND POSSIBLY A SECONDARY INFECTION (ERYSIPELAS).

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 07/05/2023. 1. H6. HEALTH EFFECT - IMPACT CODE - CHANGED TO 4619. MEDICAL DEVICE PROBLEM CODE - CHANGED TO 1126. INVESTIGATION FINDINGSCODE - CHANGED TO 4248. INVESTIGATION CONCLUSION CODE - CHANGED TO 61. 2. H11. ATTACHED: UPON ARRIVAL TEST. FINAL TEST. IN SERVICE REPORT (RETRAIN).

    Description of Event or Problem · 0

    A TISSUE NECROSIS IN THE SUPRAPUBIC REGION (MONS) FOLLOWING A REDUCTION TREATMENT WITH BODYTITE. SUSPICIOUS FOR ERYSIPELAS AS THE UNDERLYING TISSUE BLANCHED FEW DAYS AFTER. A WEEK LATER, THE WOUNDS EVOLVED AND PSEUDOESCHAR WAS SEEN. IN THE LAST PHOTO THERE IS SIGNIFICANT STRAW-COLORED DRAINAGE, POSSIBLY A SMALL SEROMA DRAINING FROM A FULL THICKNESS WOUND.

    Description of Event or Problem · 0

    A TISSUE NECROSIS IN THE SUPRAPUBIC REGION (MONS) FOLLOWING A REDUCTION TREATMENT WITH BODYTITE. SUSPICIOUS FOR ERYSIPELAS AS THE UNDERLYING TISSUE BLANCHED FEW DAYS AFTER. A WEEK LATER, THE WOUNDS EVOLVED AND PSEUDOESCHAR WAS SEEN. IN THE LAST PHOTO THERE IS SIGNIFICANT STRAW-COLORED DRAINAGE, POSSIBLY A SMALL SEROMA DRAINING FROM A FULL THICKNESS WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170569 BODYTITE FACETITE GEI INMODE LTD AG606972A 17290016633211

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention