BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 4234468 · Received October 31, 2014

    Report

    Report Number
    1062474-2014-00001
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    August 12, 2009
    Report Date
    October 30, 2014
    Manufacturer
    MYELOTEC, INC.
    Product Code
    HRX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC DEVICE TYPE WAS NOT DOCUMENTED IN THE LAWSUIT CLAIM, COMPLAINANT LISTED SEVERAL DEVICES MANUFACTURED BY MYELOTEC BUT DID NOT INDICATE A SPECIFIC DEVICE OR LOT NUMBER THAT WAS USED IN THE EVENT AS DESCRIBED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, MYELOTEC, INC., RECEIVED A COMPLAINT FROM LAWYER FILED HIS COMPLAINT AGAINST 27 HEALTHCARE PROVIDERS AND FACILITIES INVOLVED IN THE CARE OF THE SUBJECT PATIENT-PLAINTIFF, AND ALSO HAS ATTEMPTED TO ALLEGE PRODUCT LIABILITY THEORIES AGAINST MYELOTEC, INC. PLAINTIFF ALLEGEDLY UNDERWENT AN UNSPECIFIED SURGICAL INTERVENTION TO HIS CERVICAL SPINE ON (B)(6) 2009 AT (B)(6). PLAINTIFF CONTENDS VARIOUS MEDICAL PROFESSIONALS WERE NEGLIGENT AND ALSO ACTED FRAUDULENTLY WITH REGARD TO HIS CARE AND TREATMENT. PLAINTIFF'S ALLEGED INJURIES INCLUDE PAIN, SUFFERING MENTAL ANGUISH, AND FUTURE MEDICAL EXPENSES. THE COMPLAINT CONTAINS NO SPECIFIC INFORMATION REGARDING THE MYELOTEC MEDICAL DEVICE ALLEGEDLY AT ISSUE IN THE SURGERY. THE COMPLAINT GENERALLY REFERENCES THE MYELOTEC VIDEO GUIDE CATHETER, NAVICATH STEERABLE CATHETER, AND ENDOSCOPE. A SPECIFIC DEVICE NAME AND LOT NUMBER WAS NOT PROVIDED, NOR WAS MYELOTEC DEVICE ALLEGEDLY ASSOCIATED WITH THIS EVENT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697966 ARTHROSCOPE HRX MYELOTEC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other