BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2010650 · Received February 24, 2011

    Report

    Report Number
    1213643-2011-00051
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    February 2, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR 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." IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS TO TREAT THE INFECTION. IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE PROVIDED INFORMATION. WHILE INFECTION IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. A DHR REVIEW HAS BEEN CONDUCTED, INCLUDING STERILITY. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE. NO MANUFACTURING ISSUE WERE IDENTIFIED.

    Description of Event or Problem · 1

    PER PROVIDED MEDICAL RECORDS: ON (B)(6) 2011: PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF LEFT INDIRECT INGUINAL HERNIA WITH INSERTION OF 4 X 6 MESH. ON (B)(6) 2011: PATIENT STARTED ON ORAL ANTIBIOTICS WITH NO IMPROVEMENT WITH REDNESS. FROM (B)(6) 2011: PATIENT PRESENTED WITH PERI-UMBILICAL ABDOMINAL ERYTHEMA, ABDOMINAL PAIN AND DRAINAGE. PATIENT WAS CONSULTED BY INFECTIOUS DISEASE, AND RECEIVED IV ANTIBIOTIC (VANCOMYCIN) AND DEVELOPED A BODY RASH REACTION FROM IT, RED MAN'S SYNDROME. DERMATOLOGY WAS CONSULTED, RECOMMENDED THE RASH FELT MORE LIKE A CONTACT DERMATITIS WITH A MIX OF CELLULITIS. RASH INCREASED OVER SEVERAL DAYS DURING HOSPITAL STAY AND THEN LESSENED. PATIENT DISCHARGED HOME WITH ORAL ANTIBIOTICS AND TOPICAL (STEROID) CREAM TO FOLLOW-UP WITH AN ALLERGIST REGARDING RASH REACTION TO VANCOMYCIN. DISCHARGE DIAGNOSIS: 1) ABDOMINAL WALL CELLULITIS, S/P ABDOMINAL HERNIA REPAIR ON (B)(6) 2011, 2) CONTACT DEMATITIS, 3) RED-MAN SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUF1489

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention