BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 2190418 · Received July 29, 2011

    Report

    Report Number
    1213643-2011-00361
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    April 26, 2011
    Report Date
    July 5, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052155
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. THE SURGEON STATED THAT THE MESH WAS CUT BEFORE PLACING AND THIS CAUSED THE EDGES OF THE MESH TO BE PRICKLY AND CAUSED THE INITIAL PAIN. THE SURGEON BELIEVES THAT THE SOFTENING OF THE MESH AND THE PAIN MANAGEMENT GOT THE PROBLEM UNDER CONTROL, BUT THEN THE MESH STARTED TO SHRINK AND BECAUSE THE FIBROSIS WAS SO EXTENSIVE IT HAD PROBABLY INCORPORATED THE NERVE AND THAT THIS PULLING ON THE NERVE CAUSED THE SECOND ROUND OF PAIN. BASED ON THE INFORMATION CURRENTLY AVAILABLE, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONALLY, NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. A DHR REVIEW HAS BEEN PERFORMED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE AND THERE WAS NO EVIDENCE OF A MANUFACTURING CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    NI/NI/NI - PATIENT PRESENTED WITH SHARP STABBING PAIN 2 WEEKS POST OPERATIVELY. TREATED WITH TRAMADOL, GABEPENTIN, AND LOCAL ANAESTHETIC INJECTIONS. ON (B)(6) 2011 - A SECOND WAVE OF PAIN PROBLEMS OCCURRED CAUSING THE SURGEON TO REOPERATE AND REMOVE THE MESH. MESH WAS FOUND TO HAVE CAUSED EXTENSIVE FIBROSIS AND THE MESH HAD SHRUNK TO APPROXIMATELY 2.5CM X 2.5CM. PATIENT IS CURRENTLY PAIN FREE FOLLOWING REMOVAL OF THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD SOFT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUA1343

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R