BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 4202282 · Received October 15, 2014

    Report

    Report Number
    1213643-2014-00376
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    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 OR PT INJURY AND MEDICAL RECORDS WERE LIMITED TO THE PT'S PERI-OPERATIVE RECORD ONLY. WITHOUT A LOT NUMBER A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVAL. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. 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 WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY. ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A BARD/DAVOL FLAT MESH DURING AN UNSPECIFIED PELVIC PROCEDURE. THE ATTORNEY'S REPORT ALLEGES UNSPECIFIED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654032 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other