BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 4071217 · Received September 2, 2014

    Report

    Report Number
    1213643-2014-00310
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    August 5, 2014
    Manufacturer
    DAVOL INC, SUB C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDEME
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE 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.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: (B)(6) 2006 - THE PT WAS IMPLANTED WITH A BARD/DAVOL FLAT MESH AND A NON-DAVOL TVT IMPLANT. THE ATTORNEY'S REPORT ALLEGES PAIN, INJURY, DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532322 BARD FLAT MESH FTL DAVOL INC, SUB C.R. BARD, INC. NA 43DND496

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability