BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAT MESH

    MDR report key: 2915512 · Received January 9, 2013

    Report

    Report Number
    1213643-2013-00009
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 13, 2012
    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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, TWO EVENTS WERE REPORTED BY THE PTS' ATTORNEY (REPORTED TO FDA VIA MDR #1213643-2012-00409 AND 1213643-2012-00412). HOWEVER, REVIEW OF ADDITIONAL MEDICAL RECORDS SHOWED THERE TO BE ANOTHER IMPLANT. SUBSEQUENTLY, DAVOL, INC. IS SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFO RECEIVED. BASED ON THE INFO CURRENTLY AVAILABLE, IT IS NOT KNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE ALLEGED ISSUES EXPERIENCED BY THE PT. LESS THAN A MONTH FOLLOWING IMPLANT OF THE BARD FLAT MESH, THE PT WAS TREATED FOR WOULD CELLULITIS. THE INFLAMMATION RECURRED TWICE IN (B)(6) 2010. THERE WAS NO INDICATION IN THE MEDICAL RECORDS THAT THE MESH WAS DEFECTIVE AND REMAINS IN THE PT. THE PT HAS CO-MORBIDITIES INCLUDING OBESITY, AND HYPERTENSION. THE PT HAS ALSO UNDERGONE NUMEROUS HERNIA REPAIR AND ABDOMINAL SURGERIES. BASED ON THE INFO CURRENTLY AVAILABLE, IT IS NOT KNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE ALLEGED ISSUES EXPERIENCED BY THE PT. MEDICAL RECORDS INDICATE THAT THE PT WAS TREATED FOR CELLULITIS INFLAMMATION IS LISTED IN THE IFU AS A POSSIBLE ADVERSE REACTION. THERE WAS NO LOT NUMBER INCLUDED IN THE MEDICAL RECORDS PROVIDED THEREFORE, A MFG REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED. NO SAMPLE HAS BEEN RETURNED AS IT REMAINS IN THE PT THEREFORE, NO EVALUATION COULD BE PERFORMED. WITH THE CURRENTLY AVAILABLE INFO, NO FIRM CONCLUSIONS CAN BE DRAWN. SHOULD ADDITIONAL EVENT AND/OR EVALUATION INFO BECOME AVAILABLE, THIS FILE WILL BE REVISITED AND A FOLLOW-UP MDR SUBMITTED IF APPLICABLE.

    Description of Event or Problem · 1

    THE INITIAL ATTORNEY REPORT ALLEGED POSTOPERATIVE CELLULITIS WITH ORAL ANTIBIOTICS AFTER THE IMPLANT OF A BARD FLAT MESH. THE FOLLOWING BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2008: REPAIR OF RECURRENT INCISION HERNIA WITH IMPLANT OF BARD FLAT MESH IN THE RIGHT LOWER QUADRANT. ON (B)(6) 2008: PT TREATED FOR WOUND CELLULITIS. ON (B)(6) 2010: PT TREATED FOR WOUND CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12122 FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention