BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3070727 · Received April 15, 2013

    Report

    Report Number
    1213643-2013-00148
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    April 27, 1998
    Report Date
    March 26, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    N
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSION CAN BE MADE. THE MEDICAL RECORDS INDICATE THAT THREE YEARS POST IMPLANT THE PT UNDERWENT A SECOND PROCEDURE FOR STRESS INCONTINENCE DURING WHICH A NON-BARD MESH WAS PLACED. FOLLOWING THAT PROCEDURE SHE PRESENTED WITH PAIN, NAUSEA, AND VOMITING. DURING AN EXPLORATION OF THE INCISION IT APPEARS THAT BOTH MESH WERE EXCISED. WORK-UPS ALL REVEALED NORMAL RESULTS AND SHE WAS DISCHARGED ON DAY FIVE. THE PT'S CLINICAL COURSE IS NOT KNOWN BEYOND THIS TIME. CURRENTLY, ON CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE DAVOL PRODUCT IN QUESTION. THE PRODUCT WAS MANUFACTURED BY SURGICAL SENSE, PRIOR TO THE DAVOL ACQUISITION OF THE PRODUCT. MFG RECORDS FROM SURGICAL SENSE ARE NOT READILY AVAILABLE FOR REVIEW. THEREFORE, NO DHR WILL BE PERFORMED RELATED TO THIS COMPLAINT. ADDITIONALLY, NO SAMPLE HAS BEEN RETURNED FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY. ON (B)(6) 1995, PT UNDERWENT A PROCEDURE TO TREAT STRESS INCONTINENCE. DURING THIS PROCEDURE, A BARD FLAT MESH WAS PLACED. ON (B)(6) 1998, PT UNDERWENT A PROCEDURE TO TREAT STRESS INCONTINENCE. DURING THIS PROCEDURE, A NON-BARD MESH WAS PLACED. THERE WAS NO MENTION OF THE BARD FLAT MESH IN THE OPERATIVE REPORT. ON (B)(6) 1998, PT PRESENTED WITH DRAINAGE FROM HER INCISION SITE, LOWER ABDOMINAL PAIN, NAUSEA, AND VOMITING. SHE UNDERWENT EXPLORATION OF INCISION AND THE BARD FLAT MESH AND THE NON-BARD MESH WERE BOTH EXCISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161268 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 761040

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability