BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROAIRE

    MDR report key: 4895822 · Received June 26, 2015

    Report

    Report Number
    2020601-2015-00046
    Event Type
    Death
    Date Received
    June 26, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 26, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    MUU
    PMA / PMN Number
    K981922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO DEATH OF PATIENT, THE OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA. FOLLOW-UP #1: AS NOTED, 'ADVERSE EVENT OR PRODUCT PROBLEM," MICROAIRE SURGICAL INSTRUMENT DEVICES WERE NOT THE CAUSE OF PATIENT EXPIRATION. ALSO, ADDITIONAL INFORMATION SUCH AS THE DATE OF DEATH, PRODUCT NUMBER, SERIAL NUMBER, AND DEVICE MANUFACTURE DATE HAVE BECOME AVAILABLE. THIS REPORT IS BEING SENT TO THE FDA AS AN UPDATE, SUPPLEMENTAL TO THE ORIGINAL REPORT.

    Additional Manufacturer Narrative · 1

    ON 16NOV2017 DURING A REVIEW OF MDR FILES, IT WAS IDENTIFIED THAT MDR#2020601-2015-00046 WAS FILED IN THE MAUDE DATABASE WITH A PRODUCT CODE (BOX D. 2B) OF HWC. THIS CORRECTION FOLLOW-UP IS BEING SUBMITTED TO CHANGE THE PROCODE TO MUU.

    Additional Manufacturer Narrative · 1

    DUE TO DEATH OF PT, THE OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    A PT IN THE (B)(6) WAS UNDERGOING A LIPOSUCTION PROCEDURE WITH FAT TRANSFER (WE HAVE NO INFO AT THIS TIME AS TO WHAT SYSTEM WAS USED FOR THE FAT TRANSFER). THE PROCEDURE TOOK PLACE AT (B)(6) HOSPITAL WHEN THE PATIENT GOT SICK AND WAS TRANSFERRED TO ANOTHER HOSPITAL. THE PT LATER DIED FROM UNK CAUSES. DATES AND FURTHER DETAILS ARE NOT KNOWN AT THIS TIME.

    Description of Event or Problem · 1

    FOLLOW-UP #1: (B)(6), ASSISTANT THEATER MANAGER STATED ON A CONFERENCE CALL ON JULY 2, 2015 THAT MICROAIRE SURGICAL INSTRUMENT DEVICES WERE NOT THE CAUSE OF THE PATIENT EXPIRATION. IN ADDITION, FURTHER DETAILS ARE NOW AVAILABLE ON THE DATE OF DEATH, PRODUCT NUMBER, SERIAL NUMBER, AND DEVICE MANUFACTURE DATE AND ARE NOTED IN THIS FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416389 MICROAIRE PAL LIPOSCULPTOR ELECTRIC HANDPIECE MUU MICROAIRE SURGICAL INSTRUMENTS, LLC PAL-600E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death