BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5011197 · Received August 18, 2015

    Report

    Report Number
    3003910212-2015-00041
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    April 10, 2015
    Report Date
    August 27, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE.

    Additional Manufacturer Narrative · 1

    REPORTABLE EVENT INFORMATION WAS ERRONEOUSLY SENT TO W. L. GORE & ASSOCIATES, INC. ON 08/11/2015. ON 08/27/2015 THE COMPLAINANT CONTACTED GORE AND A VERBAL DISCUSSION ENSUED. IT WAS REVEALED THAT THE IMPLANTED MESH WAS NOT MANUFACTURED BY GORE. THE PURPOSE OF THIS SUPPLEMENTAL REPORT IS TO NOTIFY FDA THAT THE MANUFACTURER OF THE DEVICE IMPLANTED / EXPLANTED IN THE PATIENT IS BARD ¿ DAVOL, INC. AND NOT W. L. GORE & ASSOCIATES, INC. (B)(4)

    Description of Event or Problem · 1

    GORE RECEIVED AN EMAIL FROM THE COMPLAINANT INFORMING US OF THE FOLLOWING: I WAS OPERATED ON FOR HERNIA OPERATION (B)(6) 2015 AND THE DOCTOR FOUND 'GORTEX STYLE MESH' GROWING INTO MY STOMACH FROM A PREVIOUS HERNIA OPERATION. I'VE BEEN VERY SICK FOR YEARS WITH THIS AND I WOULD LIKE TO FIND SOMEONE TO HELP ME. I HAD IT REMOVED AND HAVE OP REPORTS AND PICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546105 UNKNOWN FTM W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention