BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALIGHT ST W/ECHO

    MDR report key: 2930484 · Received January 7, 2013

    Report

    Report Number
    1213643-2013-00005
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 11, 2012
    Manufacturer
    DAVOL INC (A BARD COMPANY)
    Product Code
    FTL
    PMA / PMN Number
    K110820
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE USER FACILITY ALLEGES THE PATIENT DEVELOPED A BULGE AND UNDERWENT EXPLANT OF THE VENTRALIGHT ST MESH. ALTHOUGH IT WAS NOT DIRECTLY ALLEGED AS A RECURRENCE, IT APPEARS THE PATIENT DEVELOPED AND WAS TREATED FOR A RECURRENCE WHICH IS A KNOWN ADVERSE EVENT LISTED IN THE IFU. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION. WITH THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN. ADDITIONAL INFORMATION FROM THE VOLUNTARY REPORT: (B)(4) 2012, VENTRALIGHT ST ECHO MESH.

    Description of Event or Problem · 1

    PATIENT HAD THE DEVICE IMPLANTED FOR A VENTRAL HERNIA IN (B)(6) 2011. PATIENT RETURNED WITH A BULGE OF THE DEVICE AND HAD A RE-REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6282 VENTRALIGHT ST W/ECHO VENTRAL HERNIA MESH FTL DAVOL INC (A BARD COMPANY) 5955810 HUVE0435

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention