BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX (8.0)

    MDR report key: 3042199 · Received April 4, 2013

    Report

    Report Number
    3007215625-2013-00022
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFORMATION. PER THE PHYSICIAN'S OFFICE THE PROCEDURES WERE CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS. ZELTIQ REVIEWED THE SYSTEM LOGS FOR THE TREATMENT DATES AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING THE TREATMENTS. IT IS ZELTIQ'S POLICY TO BE CONSERVATIVE AND MAKE THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFORMATION IS RECEIVED ABOUT THIS CASE.

    Description of Event or Problem · 1

    A MALE PT IN (B)(6) RECEIVED COOLSCULPTING TREATMENT IN (B)(6) 2012 ON HIS UPPER AND LOWER ABDOMEN WITH THE COOLMAX APPLICATOR (8.0). ON (B)(4) 2013, ZELTIQ WAS INFORMED THAT THE PT HAD RETURNED TO THE OFFICE COMPLAINING OF A "DEFORMITY" AND A HARDENING OF THE FAT. ON THIS DATE, ZELTIQ ALSO RECEIVED BEFORE AND AFTER PHOTOS WHICH CONFIRMED AN ENLARGEMENT IN THE TREATED AREAS. ON (B)(4) 2013, ZELTIQ RECEIVED CONFIRMATION FROM THE TREATING PHYSICIAN THAT THE PT HAD RETURNED TO THE OFFICE ON (B)(6) 2013. THE TREATING PHYSICIAN REPORTED THAT THE FAT IN THE UPPER AND LOWER ABDOMEN FELT FIRM, ENLARGED, AND "NON-MALLEABLE." THE PT REPORTED THAT HE HAD LOST WEIGHT BUT DID NOT ALLOW THE OFFICE TO WEIGH HIM. IT IS LIKELY THAT INTERVENTION WILL BE REQUIRED TO TREAT THE CONDITION, MAKING THIS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138529 ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS, INC. COOLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention