BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 12757111 · Received November 7, 2021

    Report

    Report Number
    3007215625-2021-01933
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 7, 2021
    Report Date
    May 22, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA. FIELD SERVICE WAS PERFORMED. INCOMING EXTERNAL INSPECTION: UMBILICAL CORD: ¿ IN POOR CONDITION: WIRING WAS OVER EXTENDED AND INSULATION WAS RETRACTED AND DISLODGED OUTSIDE OF THE ALL-IN-ONE ASSEMBLY HOUSING AS CUSTOMER RECOUNTED. ¿ INSULATION HAD MULTIPLE INGRAINED DIRT MARKS ACROSS THE LENGTH OF THE BRAID. ALL-IN-ONE: ¿ ONE OF THE SCREW INSERT FROM THE INNER MOLDING WAS CRACKED CAUSING THE HOUSING NOT TO FASTEN SECURELY TO THE UMBILICAL CORD. ¿ SLIGHT AMOUNT OF GEL CONTAMINATION AROUND THE INNER EDGES OF THE BRACKET AND PINS APPLICATOR HEAD: ¿ THE FRONT LATERAL SIDE OF THE BOTTOM COVER HAD AN APPARENT MOLDING DAMAGE FROM TRAUMA ¿ TOP COVER HAD VISIBLE SCRATCHES ¿ VERIFIED LATCHES ARE NEWER VERSION ¿ APPLICATOR SEAL IS INTACT WITH NEGLIGIBLE GAP INCOMING TEST: THE APPLICATOR WAS CONNECTED TO THE RMA TEST FIXTURE. ¿ PERFORMED AND PASSED ENGINEERING QUICK CHECK TEST. ¿ PERFORMED AND PASSED ZORA FINAL CHANNEL TEST. ¿ PERFORMED AND PASSED BUTTON TEST. ¿ PERFORMED AND PASSED LED TEST. ALL CYCLES COMPLETED WITHOUT ERRORS. INCOMING INTERNAL INSPECTION: THE APPLICATOR WAS OPENED AND INSPECTED; THERE WERE MINIMAL GEL INGRESS AND CONTAMINATION WITHIN THE FOLLOWING: ¿ CORRESPONDING FRONT AND BACK-END INSULATION FOAMS ¿ WATER AND VACUUM TUBING INSULATION ¿ BOARDS WITH THEIR CORRESPONDING INSULATING AND GROUNDING PLATE FOAMS WERE UNSCATHED REPAIRED AND REPLACED: 205560 INSULATION END FOAM (QTY 2) 205231 FOAM (QTY 2) 205561 BOTTOM HOUSING FOAM (QTY 2) 205559 BASE HOUSING 204315 CIRCULAR PLUG INSULATION PIECES (QTY 4) 204347 TOUCHPAD 204299 TOP COVER 205237 END STRIPS (QTY 2) 204467 SIDE INSULATION (QTY 2) 204297 SIDE COVERS (QTY 2) 203879 DECAL SIDE COVERS (QTY 2) 204345 DECAL 206696 IFU 207204 COOLCORE TEMPLATE 207205 COOLCURVE+ TEMPLATE 204578 COOLADVANTAGE PLUS TEMPLATE 205904 DUMMY CONTOUR (QTY 2) 205867 PLUGS (QTY 4) CS302474 PLUGS (QTY 4) 204356 BOX CS 304617 CARTON, SHIPPING, OUTER, LARGE CS 305653 FOAM, CORNER (QTY 4) IN HOUSE: 200264 UMBILICAL CABLE CA PLUS FINAL TEST: ¿ PERFORMED AND PASSED DR 13693 REV AJ SERVICE MATRIX. ¿ FLUSHED APPLICATOR; PERFORMED AND PASSED PROCEDURE #206526 APPLICATOR FLOW RATE DIAGNOSTIC PROCEDURE AND VACUUM TEST ¿ PERFORMED AND PASSED FINAL TEST. CAUSE: ¿ CONFIRMED CUSTOMER¿S REPORTED PROBLEM; UMBILICAL CORD WAS DISENGAGED FROM THE ALL-IN-ONE HOUSING EXPOSING THE INSULATED WIRES. APPLICATOR MAY HAVE BEEN DROPPED OR SUSTAINED CONSIDERABLE TRAUMA EVIDENCED BY THE CRACKED SCREW INSERT FROM THE ALL-IN-ONE AND FRONT LATERAL BOTTOM HOUSING DAMAGE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1, D4, D8, G1.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION CURRENTLY AVAILABLE, ALTHOUGH NO ADVERSE EVENT WAS REPORTED, THERE IS A POSSIBILITY OF: BURN AND ELECTRIC SHOCK THAT COULD BE CAUSED BY EXPOSURE TO UNINSULATED ELECTRIC CIRCUITS. DEVICE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A COOLADVANTAGE PLUS APPLICATOR WITH EXPOSED WIRES. THE EVENT APPEARED OUTSIDE TREATMENT AND NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A COOLADVANTAGE PLUS APPLICATOR WITH EXPOSED WIRES. THE EVENT APPEARED OUTSIDE TREATMENT AND NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF OF A COOLADVANTAGE PLUS APPLICATOR WITH EXPOSED WIRES. THE EVENT APPEARED OUTSIDE TREATMENT AND NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655310 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown