BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO MESH

    MDR report key: 1982245 · Received January 25, 2011

    Report

    Report Number
    1213643-2011-00028
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    October 20, 2009
    Report Date
    January 4, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K081777
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THAT INITIAL REPORTER TO REQUEST ADDITIONAL 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 INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR AN INFECTION ALONG WITH A NON-HEALING WOUND. 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." THE INFO PROVIDED INDICATES ATTEMPTS WERE MADE TO TREAT THE INFECTION WITH WOUND CARE AND ANTIBIOTICS, HOWEVER, NON-HEALING WOUND PROMPTED THE EXPLANT OF THE BARD VENTRIO MESH. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. 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. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE. NO MFG ISSUES WERE IDENTIFIED. SEE MDR 1213643-2011-00027 FOR INFO RELATED TO THE BARD COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2008.

    Description of Event or Problem · 1

    INFO FROM MEDICAL RECORDS RECEIVED FOR REVIEW: (B)(6) 2008 - INCISIONAL HERNIA REPAIR W/BARD COMPOSIX KUGEL MESH. ON (B)(6) 2009 - INCARCERATED VENTRAL HERNIA REPAIR W/BARD VENTRIO MESH. PREVIOUSLY PLACED COMPOSIX KUGEL MESH WAS NOTED TO HAVE A CURLED-UP EDGE, HOWEVER, SURGEON NOTES HE WAS UNABLE TO GET EDGE TO LAY FLAT. ON (B)(6) 2009 - OFFICE VISIT, PT PRESENTS WITH SMALL OPENING ON LOWER ASPECT OF INCISION, NO REDNESS. ANTIBIOTIC TREATMENT, WOUND CARE. ON (B)(6) 2009 - OFFICE VISIT, WOUND CLEAN, NO CELLULITIS, MESH SEEN AT BASE OF WOUND. ON (B)(6) 2009 - OFFICE VISIT, LOW GRADE FEVER, INTENSE PAIN W/USE OF WOUND VAC. WOUND CLEAN, MESH EXPOSED. ON (B)(6) 2009 - OFFICE VISIT, WOUND CLEAN, NO PURULENT DRAINAGE, MESH STILL EXPOSED. ON (B)(6) 2009 - WOUND EXCISION W/BARD VENTRIO MESH EXCISION AND VENTRAL HERNIA REPAIR. ON (B)(6) 2010 - REPAIR OF RECURRENT INCISIONAL HERNIA W/BARD COMPOSIX KUGEL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRIO MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA DASL0020

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention