BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION

    MDR report key: 2730707 · Received August 31, 2012

    Report

    Report Number
    3007738819-2012-00006
    Event Type
    Other
    Date Received
    August 31, 2012
    Report Date
    August 7, 2012
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP FOR EVALUATION. AFTER RECEIVING THIS REPORT, OLYMPUS TERUMO BIOMATERIALS CORP. REAFFIRMED AS FOLLOWS: NYLON RAYON IS NOT USED FOR THE MFG PROCESS OF FOUNDATION, INCLUDING ITS SURROUNDING PROCESS. (B)(4). NYLON RAYON IS NOT INCLUDED IN MAIN MATERIAL AND OTHER MATERIALS; IT WOULD BE IMPOSSIBLE TO CONTAMINATE WITH THE NYLON RAYON SUBSTANCE DURING THE MFG PROCESS BECAUSE ITS CONTROL IS CLOSELY-SUPERVISED TO CLEAN AREA AND CLEAN BENCH. IN CONCLUSION, THE MFR ARE CONFIDENT THAT NYLON/RAYON HAS NO PART OF FOUNDATION.

    Description of Event or Problem · 1

    FOUR (4) YEARS AGO, THE PT CAME INTO OFFICE (DENTAL CLINIC) FOR AN EXTRACTION OF #3. RECENTLY, THE PT FOUND THAT SHE HAD NYLON RAYON IN SKIN AROUND NECK AREA. THE PT SAID THERE WAS FLOSS LOOKING MATERIAL, COMING OUT THE PT'S SKIN AND AROUND PT'S NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY FOUNDATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1