BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX L/P

    MDR report key: 1707028 · Received May 26, 2010

    Report

    Report Number
    1213643-2010-00253
    Event Type
    Death
    Date Received
    May 26, 2010
    Report Date
    April 28, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061754
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    DAVOL BECOME AWARE OF THIS EVENT DURING A SEARCH OF THE FDA MAUDE EVENT REPORT DATABASE. DAVOL WAS NOT AND HAS NOT BEEN CONTACTED BY THE INITIAL REPORTER OF THE EVENT WHO REPORTED THE EVENT TO (B) (4). WE HAVE CONTACTED THE (B) (4) MANUFACTURER CONTACT LISTED ON MAUDE EVENT REPORT #1219930-2009-00539 TO REQUEST ADDITIONAL INFORMATION. THE REPORTER COMMUNICATED THAT (B) (4) HAS NOT RECEIVED ANY INFORMATION THAT IDENTIFIED THERE WAS A PRODUCT CONCERN WITH THE COMPOSIX L/P PRODUCT. THE (B) (4) CONTACT PERSON REPORTED THAT ALL ATTEMPTS HAVE BEEN MADE TO ACQUIRE THE FIXATION DEVICE AS WELL AS ALL OTHER ADDITIONAL INVESTIGATION INFORMATION FROM THE COMPLAINANT AND THAT (B) (4) DOES NOT HAVE ANY INFORMATION ON THE COMPOSIX L/P MESH THAT WAS USED WITH THE FIXATION DEVICE. THEREFORE, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE EVENT WAS ORIGINALLY REPORTED TO THE FDA BY (B) (4) (MANUFACTURER OF THE ABSORBATACK 5MM ABSORBABLE FIXATION DEVICE) UNDER REPORT #1219930-2009-00539. PER THAT MAUDE EVENT REPORT: PROCEDURE: LAP VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: ALL THE TACKS PLACED ON THE RIGHT SIDE OF THE MESH FELL OFF 1ST POST OPERATIVE DAY. COMPOSIX LP 22 X 26 CM WAS THE MESH USED. SMALL BOWEL PERFORATION AND WAS REPAIRED IN 2009. THE PATIENT EXPIRED 1 MONTH POST-OPERATIVE AT HOME. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX L/P FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death