BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTFE MESH

    MDR report key: 3232240 · Received July 8, 2013

    Report

    Report Number
    1213643-2013-00288
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 19, 2013
    Manufacturer
    DAVOL INC., SUB C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT, ADDITIONALLY NO PRODUCT WAS RETURNED FOR EVAL. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE MADE. 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 PROVIDED TO DAVOL BY THE PT'S ATTORNEY: ON (B)(6) 2006, PT WAS IMPLANTED WITH A NON-DAVOL IMPLANT AND A DAVOL FLAT MESH DURING AN UNK VAGINAL PROCEDURE. THE ATTORNEYS 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
    310289 PTFE MESH FTL DAVOL INC., SUB C.R. BARD, INC. NA 43EQD227

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability