BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 2202571 · Received August 5, 2011

    Report

    Report Number
    1213643-2011-00367
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    April 20, 2005
    Report Date
    July 29, 2009
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K052155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, THIS COMPLAINT WAS NOT MDR REPORTABLE HOWEVER MEDICAL RECORDS PROVIDED INDICATE AN UNSPECIFIED SURGICAL INTERVENTION (DRAIN PLACEMENT AND ANTIBIOTICS) WHICH IS WHY WE ARE NOW SUBMITTING THIS AN AN INITIAL MDR. BASED ON THE MEDICAL RECORDS PROVIDED THE PATIENT UNDERWENT BILATERAL DIRECT INGUINAL HERNIA REPAIR WITH TWO PIECES OF BARD SOFT MESH (KEYHOLE); ONE ON LEFT AND ONE ON RIGHT. FOLLOWING THE REPAIR THE PATIENT WAS SEEN IN MULTIPLE OFFICE VISITS WITH COMPLAINTS OF PAIN. ON (B)(6) 2005, THE PATIENT HAD A DRAIN PLACED AND BEGAN ANTIBIOTICS ALTHOUGH THE MEDICAL RECORDS NOTE THERE WAS NO OBVIOUS SIGN OF INFECTION. THE MEDICAL RECORDS NOTE THAT ON (B)(6) 2005 THE PATIENT WAS STILL COMPLAINING OF PAIN HOWEVER DECLINED AN EXPLORATORY SURGERY. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH THERE IS NO CONFIRMATION OF THE PRESENCE OF AN INFECTION, 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." ADDITIONALLY, IT APPEARS THE MESH REMAINS IMPLANTED. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT: (B)(6) 2005 - PATIENT UNDERWENT BILATERAL DIRECT INGUINAL HERNIA REPAIR WITH TWO PIECES OF BARD SOFT MESH (KEYHOLE); ONE ON LEFT AND ONE ON RIGHT. ON (B)(6) 2005 - OFFICE VISIT, PATIENT COMPLAINS OF RIGHT GROIN PAIN AND SWELLING. NO OBVIOUS SIGN OF INFECTION, DRAIN PLACED, ANTIBIOTICS STARTED. ON (B)(6) 2005 - OFFICE VISIT, RECURRENT SEROMA. ON (B)(6) 2005 - OFFICE VISIT, PATIENT COMPLAINS OF LEFT GROIN PAIN. ON (B)(6) 2005 - OFFICE VISIT, PATIENT COMPLAINS OF PAIN, LOCAL ANESTHETIC AND STEROID INJECTION ADMINISTERED. ON (B)(6) 2005 - OFFICE VISIT, PATIENT COMPLAINS OF SEXUAL SIDE EFFECTS. ON (B)(6) 2005 - OFFICE VISIT, PATIENT CONTINUES TO COMPLAIN OF LEFT SIDED PAIN. PATIENT IS UNWILLING TO CONSENT TO EXPLORATORY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD SOFT MESH FTL DAVOL INC. NA 43KOD061

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention