BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMEND

    MDR report key: 5901448 · Received August 24, 2016

    Report

    Report Number
    2249852-2016-00014
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    July 22, 2016
    Report Date
    August 22, 2016
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    JXI
    PMA / PMN Number
    K060952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT AND EXPLANT DATES COULD NOT BE OBTAINED/VERIFIED BY COLLAGEN MATRIX, INC. FROM THE PHYSICIAN AND/OR SALES REPRESENTATIVE, THEREFORE PRODUCT STABILITY COULD NOT BE EVALUATED AND COMPARED WITH THE PRODUCT DESIGN SPECIFICATIONS. ADDITIONALLY, COLLAGEN MATRIX, INC. COULD NOT OBTAIN PRODUCT TRACEABILITY INFORMATION (I.E. LOT NUMBER, PRODUCT REFERENCE NUMBER, UDI) DURING INITIAL AND FOLLOW-UP COMMUNICATIONS, PREVENTING THE COMPANY FROM PERFORMING ANY FOLLOW-UP EVALUATIONS OR PRODUCT TESTING. NO SIMILAR INCIDENTS HAVE BEEN REPORTED TO COLLAGEN MATRIX, INC. FOR THIS PRODUCT TO DATE.

    Description of Event or Problem · 1

    CLINICIAN REPORTED THAT THE NEUROMEND TUBE WAS NOT ABSORBED AND REQUIRED A SECOND PROCEDURE TO REMOVE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554165 NEUROMEND COLLAGEN NERVE WRAP JXI COLLAGEN MATRIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other