BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1213643-2013-00408

    MDR report key: 3314191 · Received August 22, 2013

    Report

    Report Number
    1213643-2013-00408
    Event Type
    Injury
    Date Received
    August 22, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A DAVOL SALES REP REPORTED THAT IN (B)(6) 2002, THE PT WAS IMPLANTED WITH AN UNK COMPOSIX KUGEL HERNIA PATCH. ALSO REPORTED WAS THAT ON (B)(6) 2013, THE PT UNDERWENT SURGERY FOR A RECURRENT HERNIA, DURING THIS PROCEDURE, THE COMPOSIX KUGEL HERNIA PATCH WAS EXPLANTED AND THE RING OF THE PATCH WAS NOTED TO BE "BROKEN". THE EXPLANTED MESH WAS NOT RETURNED TO DAVOL FOR EVAL, NOR HAVE MEDICAL RECORDS BEEN PROVIDED. ADDITIONALLY, IT WAS REPORTED THAT THE PT HAD GAINED A SIGNIFICANT AMOUNT OF WEIGHT FOLLOWING IMPLANT OF THE COMPOSIX KUGEL HERNIA PATCH, AND THIS WAS HER 3RD OR 4TH RECURRENCE. IT IS UNCLEAR AT THIS TIME WHETHER THE PT HAD UNDERGONE ADDITIONAL SURGERIES FOLLOWING THE INITIAL IMPLANT AND IF SO WHETHER THE MESH HAD BEEN MANIPULATED DURING AN ADDITIONAL SURGERY. RECURRENCE IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED; THEREFORE, IT IS UNK WHETHER THE ALLEGED DEVICE WAS PART OF THE COMPOSIX KUGEL MESH RECALL. WITHOUT A LOT NUMBER, A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. THIS MDR INCLUDES ALL PT, EVENT, AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408813 FTL DAVOL INC., SUB. C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1