BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 3833457 · Received May 20, 2014

    Report

    Report Number
    1213643-2014-00152
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    January 1, 2005
    Report Date
    April 23, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENTLY AVAILABLE INFO WE ARE UNABLE TO DETERMINE TO WHAT EXTENT THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. NO PRODUCT IDENTIFIERS HAVE BEEN PROVIDED, HOWEVER BASED ON THE DATE OF IMPLANT, IT IS POSSIBLE THAT THE SUBJECT PRODUCT IS PART OF THE COMPOSIX KUGEL RECALL. ADD'L INFO HAS BEEN REQUESTED, TO DATE, NO MEDICAL DOCUMENTATION HAD BEEN PROVIDED ASSOCIATED TO THIS MESH. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THE PT ALLEGES INFECTION WHICH IS A KNOW POSSIBLE ADVERSE REACTION LISTED IN THE IFU. THE WARNING SECTION OF THE IFU STATES " IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." THE PT ALLEGES THAT A "CORKSCREW OR RING" WAS EXPLANTED FROM THE MESH, HOWEVER THE EXPLANTED PORTION WAS NOT RETURNED, NOW WERE ANY PATHOLOGY REPORTS PROVIDED. THIS MDR INCLUDES ALL PT, EVENTS AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. SEE MDR 1213643-2014-00153 FOR INFO RELATED TO THE COMPOSIX KUGEL HERNIA PATCH ALLEGED TO HAVE BEEN IMPLANTED ON (B)(6) 2004.

    Description of Event or Problem · 1

    THE FOLLOWING HAS BEEN ALLEGED BY THE PT: NI/NI/2004 - PT ALLEGES THAT HE WAS IMPLANTED WITH A COMPOSIX KUGEL HERNIA PATCH FOR REPAIR OF AN UMBILICAL HERNIA. (B)(6) 2004 - PT DEVELOPED AN ADD'L HERNIA JUST ABOVE THE PREVIOUS REPAIR AND WAS ALLEGEDLY IMPLANTED WITH A SECOND COMPOSIX KUGEL HERNIA PATCH. NI/NI/2005 - PT ALLEGED THE "CORKSCREW OR RING" PULLED OUT OF THE FIRST COMPOSIX KUGEL HERNIA PATCH AND JUST THAT PORTION WAS REMOVED. NI/NI/2006 - PT ALLEGES THAT HE DEVELOPED AN INFECTION FROM THE PREVIOUS REPAIR AND UNDERWENT A "RE-REPAIR" SURGERY. NI/NI/2009 - PT ALLEGES THAT THE SECOND COMPOSIX KUGEL HERNIA PATCH IMPLANT HAD "PULLED AWAY" AND HE UNDERWENT EXPLANT OF THAT MESH. PT ALLEGES THAT HE HAS DECREASED MOBILITY DUE TO THE CONSTANT SEVERE PAIN WHICH BEGINS IN HIS ABDOMEN AND RADIATES TO HIS LEFT HIP. HE ALLEGES THAT HIS MD/SURGEON HAS TOLD HIM THE DAMAGE HE HAS SUFFERED FROM ALL OF HIS PREVIOUS SURGERIES CANNOT BE REPAIRED AND HE WILL ALWAYS HAVE PAIN. PT IS SCHEDULED TO FOLLOW UP WITH THE SURGEON TO DETERMINE THE NEXT COURSE OF TREATMENT OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299305 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention| S