BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 4973724 · Received July 7, 2015

    Report

    Report Number
    2020601-2015-00053
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    April 13, 2015
    Report Date
    July 7, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    MUU
    PMA / PMN Number
    K150779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE PRODUCT MALFUNCTIONED DURING SURGERY, THE OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT STATED THE CUSTOMER HAD PROBLEMS W/A LIPOFILTER THAT CRACKED DURING SURGERY. (B)(4) WAS PART OF A RECALL THAT BEGAN (B)(6) 2015. LETTERS WERE SENT VIA CERTIFIED MAIL TO ALL IMPACTED CUSTOMERS, INCLUDING THIS CUSTOMER, (B)(6) MEDICAL IN (B)(6). THE MDR WAS NOT ORIGINALLY SENT DUE TO THE ITEM BEING PART OF A RECALL; HOWEVER, UPON REVIEW, IT WAS DETERMINED THAT THIS SHOULD BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437952 MICROAIRE LIPOFILTER WITH TOOMEY MUU MICROAIRE SURGICAL INSTRUMENTS ASP-CAN-4T NA

    Patients

    Seq Age Sex Outcome Treatment
    1