BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX

    MDR report key: 1903340 · Received November 10, 2010

    Report

    Report Number
    1213643-2010-00480
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    October 21, 2010
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON UNKNOWN DATE, PATIENT UNDERWENT IMPLANT DURING PARASTOMAL HERNIA REPAIR PROCEDURE. OVER AN UNKNOWN PERIOD OF TIME POST XENMATRIX IMPLANT, PATIENT DEVELOPED AN ALLERGIC REACTION WHICH WAS TREATED. THE MESH WAS SUBSEQUENTLY EXPLANTED ON UNKNOWN DATE.

    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 Other