BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 2032749 · Received March 17, 2011

    Report

    Report Number
    1213643-2011-00078
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 22, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTM
    PMA / PMN Number
    K081272
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE INFORMATION CURRENTLY AVAILABLE. FURTHERMORE, NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT UNDERWENT XENMATRIX IMPLANT. ON (B)(6) 2001 - THE GRAFT WAS REMOVED SECONDARY TO OTHER COMPLICATIONS FOR THE PATIENT. THE GRAFT WAS NOT INFECTED BUT WAS UNINCORPORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENMATRIX FTM DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention