BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 3221064 · Received July 5, 2013

    Report

    Report Number
    1213643-2013-00287
    Event Type
    Injury
    Date Received
    July 5, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO. NO PRODUCT WAS RETURNED FOR EVAL. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF THE PATIENT'S MEDICAL RECORDS WHICH WERE PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2008- PATIENT WAS IMPLANTED WITH A BARD SOFT MESH DURING A VAGINAL SLING PROCEDURE, ALSO UTILIZING ANOTHER COMPANY'S PRODUCT. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADD'L MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307088 BARD SOFT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA DAQE0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability