BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPPER MODULE, COM1

    MDR report key: 9965479 · Received April 15, 2020

    Report

    Report Number
    3007215625-2020-00033
    Event Type
    Injury
    Date Received
    April 15, 2020
    Product Code
    OOK
    UDI-DI
    00816417020001
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COOLSCULPTING SYSTEM IS A SKIN COOLING DEVICE INDICATED FOR COLD-ASSISTED LIPOLYSIS (BREAKDOWN OF FAT). THE COOLSCULPTING USER MANUAL STATES, ¿COLD PANNICULITIS RESULTS FROM INJURY TO ADIPOSE TISSUE EXPOSED TO COLD AND MAY RESULT IN A MILD TO SEVERE INFLAMMATORY RESPONSE. IN MILD CASES, THE SYMPTOMS ARE SELF-RESOLVING AND MAY INCLUDE REDNESS, SWELLING, SKIN NODULES, WARMTH, TENDERNESS, AND POSSIBLE LOW-GRADE FEVER. THESE CASES TYPICALLY RESOLVE WITHOUT LONG-TERM SEQUELAE. IN MORE SEVERE CASES, AN INTENSE INFLAMMATORY RESPONSE MAY RESULT IN MORE EXTENSIVE TISSUE DAMAGE, INCLUDING FAT NECROSIS, WHICH MAY REQUIRE MEDICAL OR SURGICAL INTERVENTION.¿ CURRENT TRENDING DATA SHOWS THE OBSERVED OCCURRENCE OF COLD PANNICULITIS/FAT NECROSIS DOES NOT EXCEED THE EXPECTED OCCURRENCE AND DOES NOT WARRANT FURTHER ACTION AT THIS TIME. ALLERGAN WILL CONTINUE TO CLOSELY MONITOR TRENDING DATA AND WILL CONSIDER FURTHER ACTION IF DEEMED NECESSARY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF/WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD MALE HAD UNDERGONE 2 CYCLES OF COOLSCULPTING IN (B)(6) 2012 AND (B)(6) 2013 TO HIS FLANKS. HE PRESENTED TO OUR HOSPITAL 6 MONTHS LATER, COMPLAINING OF BILATERAL FLANK LUMPS WITH THE RIGHT SIDE LARGER THAN THE LEFT. HE DID NOT COMPLAIN OF TENDERNESS EXCEPT WHEN WEARING BELTS. ON EXAMINATION, THERE WERE PALPABLE LUMPS ON BOTH FLANKS. ESTIMATED SIZE FOR THE RIGHT WAS ABOUT 10×10 CM, AND 8×8 CM FOR THE LEFT. THERE WERE NO FLUCTUANCE, ERYTHEMA, OR TENDERNESS ON PALPATION. THE PATIENT SUBSEQUENTLY UNDERWENT EXCISIONAL BIOPSY OF BILATERAL ABDOMINAL LUMPS AND FURTHER LIPOSUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428464 UPPER MODULE, COM1 DERMAL COOLING PACK/VACUUM/MASSAGER OOK BRZ-CG1-CUD-110 NI 00816417020001

    Patients

    Seq Age Sex Outcome Treatment
    1