BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER ASSISTED LIPOSUCTION

    MDR report key: 13367889 · Received January 26, 2022

    Report

    Report Number
    MW5107032
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    November 8, 2011
    Report Date
    January 26, 2022
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC.
    Product Code
    QPB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2011 CALLER STATED THAT SHE HAD A LIPOSUCTION DONE DURING A BREAST REDUCTION PROCEDURE. CALLER STATED THAT THE SURGEON SAID HE HAD TO DO THE LIPOSUCTION TO BALANCE HER. SHE FURTHER STATED THAT A POWER ASSISTED DEVICE WAS USED DURING THE PROCEDURE WITHOUT HER CONSENT. SHE SAID THE DEVICE DISABLED HER AND NOW SHE IS ON DISABILITY. THE DEVICE WAS USED TO REMOVE SUBCUTANEOUS FAT THAT WAS NEEDED IN HER BODY WHICH NOW RESULTS TO AN INCREASE IN THE PRODUCTION OF VISCERAL FAT THAT CAUSES DISEASE PROCESS IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735814 POWER ASSISTED LIPOSUCTION SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL QPB MICROAIRE SURGICAL INSTRUMENTS LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention