BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT CONTROL IPC REFURB

    MDR report key: 2882381 · Received December 20, 2012

    Report

    Report Number
    1045254-2012-00738
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 26, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ERL
    PMA / PMN Number
    K963246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. RESULT: RESULTS PENDING COMPLETION OF EVALUATION. CONCLUSION: CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROGRESS. METHOD: NO TESTING METHODS PERFORMED. NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THIS PRODUCT WAS BEING USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT RETURNED (B)(4) 2013. THE PINS ON THE CONNECTOR WERE TWISTED. THE PINS WERE REPAIRED, AND THE DEVICE WAS RETURNED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOT CONTROL RUNS CONTINUOUSLY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOT CONTROL IPC REFURB DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL XOMED MFG JACKSONVILLE EF200RF 64999300

    Patients

    Seq Age Sex Outcome Treatment
    1