BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTUBE

    MDR report key: 1047265 · Received May 16, 2008

    Report

    Report Number
    2183620-2008-00011
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    January 1, 2004
    Report Date
    May 16, 2008
    Manufacturer
    NEUROREGEN L.L.C.
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS FOUND THROUGH A CUSTOMER SURVEY PERFORMED 4 YEARS AFTER EVENT. NEUROTUBE WAS NOT ACQUIRED BY SYNOVIS MCA UNTIL AFTER THIS EVENT OCCURRED. NO INFORMATION CAN BE SUPPLIED BY THE SURGEON. NO DEVICE WAS RETURNED TO SYNOVIS SO NO CONCLUSION OR TESTING CAN BE PERFORMED. IT IS UNKNOWN WHAT THE LOT NUMBER, EXPIRATION DATE OR MANUFACTURE DATES ARE. MANUFACTURER OF THE DEVICE AT THE TIME OF THE EVENT WAS NEUROREGEN. SYNOVIS SURGICAL INNOVATIONS IS THE REPORTING COMPANY FOR THIS EVENT.

    Description of Event or Problem · 1

    DR. REPORTED THAT IN 2004, ONE OF HIS PATIENTS HAD AN EPISODE OF DIGITAL NEUROMA THAT REQUIRED RE-EXCISION WITH AUTOGENOUS NERVE GRAFT. NO ADDITIONAL INFORMATION IS AVAILABLE BECAUSE DR. DOES NOT HAVE ACCESS TO ANY PATIENT INFORMATION. THIS EVENT OCCURRED IN APPROXIMATELY 2004. THIS REPORT WAS FOUND THROUGH A CUSTOMER SATISFACTION SURVERY DONE BY MCA WITH DR. AT HOSPITAL. THE EVENT WOULD HAVE BEEN REPORTED TO THE MANUFACTURER IN 2004 WHICH WAS: NEUROREGEN L.L.C., 43 NO. BOND ST., BEL AIR, MD 21014. NEUROREGEN NO LONGER IS IN BUSINESS. THE EVENT OCCURRED PRIOR TO SYNOVIS ACQUIRING THE NEUROTUBE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROTUBE NERVE CUFF JXI NEUROREGEN L.L.C. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention