BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 6296030 · Received February 2, 2017

    Report

    Report Number
    1213643-2017-00061
    Event Type
    Injury
    Date Received
    February 2, 2017
    Report Date
    February 7, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL EMDR IS BEING SENT TO CORRECT THE PRODUCT CATALOG NUMBER. THE CORRECT PRODUCT NUMBER SHOULD BE 0112670 AND NOT 0112660 AS WAS ORIGINALLY REPORTED. UPDATED: DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, ADDITIONAL MFR NARRATIVE. CORRECTED: MODEL #/LOT #. 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

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006 - THE PATIENT WAS DIAGNOSED WITH PROLAPSE OF VAGINAL VAULT, CYSTOCELE AND RECTOCELE STUMP. THE PATIENT UNDERWENT A SACRAL COLPOPEXY, BURCH PROCEDURE, BILATERAL SALPINGO-OOPHORECTOMY AND REPAIR OF RECTOCELE. OPERATIVE DICTATION NOTES THE "MARLEX" (DAVOL FLAT) WAS TRIMMED TO A SLING AND SUTURED TO THE SACRUM, APPROXIMATELY S3 TO S2 WITH TWO SUTURES. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME ASSOCIATED TO THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81227 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 43EPD026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other