BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2251093 · Received September 13, 2011

    Report

    Report Number
    1213643-2011-00435
    Event Type
    Injury
    Date Received
    September 13, 2011
    Report Date
    August 22, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. THE PT REPORTED THAT HE UNDERWENT BILATERAL INGUINAL HERNIA REPAIR WITH BARD FLAT MESH ON (B)(6) 2000. IN THE PAST YEAR THE PT REPORTS PAIN IN HIPS, BILATERAL TESTICLES, HIPS AND RECTUS IN ADDITION TO NUMBNESS DOWN RIGHT LET AND FOOT. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MEDICAL RECORDS HAVE NOT BEEN PROVIDED AT THIS TIME AND IT APPEARS THE MESH REMAINS IMPLANTED. WITH THE AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2011-00434 FOR INFO RELATED TO THE ADD'L BARD FLAT MESH IMPLANTED ON (B)(6) 2000.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PT: (B)(6) 2000 - THE PT UNDERWENT OPEN REPAIR OF BILATERAL INGUINAL HERNIAS WITH BARD FLAT MESH. THE PT REPORTED OVER THE LAST YEAR AN INCREASE IN PAIN IN HIS HIPS, BILATERAL TESTICLE, RECTUM AND NUMBNESS TO HIS RIGHT LEG AND FOOT. THE PT HAD SURGICAL CONSULT WITH SURGEON WHO SUGGESTED STEROID INJECTION FOR "NERVE" PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC NA 43IJD219

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other