BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FTL

    MDR report key: 4782386 · Received May 14, 2015

    Report

    Report Number
    1213643-2015-00169
    Event Type
    Injury
    Date Received
    May 14, 2015
    Report Date
    June 16, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO CONCLUSION CAN BE MADE TO THE DEGREE TO WHICH THE MESH IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. RECURRENCE IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A KNOWN POSSIBLE COMPLICATION. THE SAMPLE WAS REQUESTED FOR RETURN, HOWEVER AT THIS TIME IT IS NOT KNOWN IF THE SAMPLE WILL BE RETURNED TO DAVOL FOR EVALUATION. IF/WHEN THE SAMPLE IS RETURNED A FOLLOW-UP MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW OF DAVOL'S MDR FILES. OUTCOMES ATTRIBUTED TO ADVERSE EVENTS: CORRECTED FIELD TO SPECIFY REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316483 FTL FTL DAVOL INC., SUB. C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention