BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH PLUS BIOMATERIAL

    MDR report key: 2111810 · Received May 26, 2011

    Report

    Report Number
    2017233-2011-00252
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    January 26, 2009
    Report Date
    May 26, 2011
    Manufacturer
    W.L. GORE AND ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K063435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT ALL PRE-RELEASE SPECIFICATIONS WERE MET. THERE ARE MANY COMPLEX CLINICAL VARIABLES, SUCH AS PATIENT CONDITION, THAT MAY HAVE CAUSED THE REPORTED INFECTION. HOWEVER, THERE IS NO AVAILABLE EVIDENCE THAT THE REPORTED EVENT WAS RELATED TO A PRODUCT MALFUNCTION OR DEFECT. INFECTION IS A WELL KNOWN RISK WITH SURGERY AND IS IDENTIFIED WITHIN THE INSTRUCTIONS FOR USE AS A POSSIBLE ADVERSE REACTION WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS. THE GORE DUALMESH BIOMATERIAL IS SUPPLIED STERILE FOR SINGLE USE ONLY. THE IFU CLEARLY INSTRUCTS THE USER: "TO HELP MAINTAIN STRICT ASEPSIS DURING SURGERY, SPECIAL PRECAUTIONS AND EXTREMELY CAREFUL PREOPERATIVE SITE PREPARATIONS ARE NECESSARY. WHEN OPERATIVE INFECTION IS SUSPECTED, DISSECTION OF INVOLVED TISSUES SHOULD BE CONSIDERED. ANY POSTOPERATIVE INFECTION SHOULD BE AGGRESSIVELY TREATED AT THE EARLIEST POSSIBLE TIME. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL." THE IFU ALSO IDENTIFIES THE POSSIBLE ADVERSE REACTIONS WITH THE FOLLOWING STATEMENT, "POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE" WHICH ARE CONSISTENT WITH THE ANTICIPATED, POTENTIAL COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE ITSELF. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A PATIENT UNDERWENT A HERNIA REPAIR IN WHICH GORE DUALMESH PLUS BIOMATERIAL WAS USED ON (B)(6) 2003. IT WAS FURTHER REPORTED TO GORE THAT ON (B)(6) 2009, THE PATIENT UNDERWENT A SECOND PROCEDURE TO DETERMINE WHY THE WOUND FROM THE PREVIOUS SURGERY WAS NOT HEALED WHEREBY THE IMPLANTED DEVICE WAS REPORTED BY THE PATIENT TO HAVE DETERIORATED AND WAS SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DUALMESH PLUS BIOMATERIAL FTL / MESH, SURGICAL, POLYMERIC FTL W.L. GORE AND ASSOCIATES WLG106 01522379

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention