BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3122557 · Received May 17, 2013

    Report

    Report Number
    1213643-2013-00209
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    April 29, 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
    TX, 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 AND ONLY PROVIDED AN IMPLANT OPERATIVE REPORT. THE REPORT ALLEGED THAT ON (B)(6) 2008, THE PT WAS IMPLANTED WITH A BARD MESH. AN IMPLANT OPERATIVE REPORT WAS PROVIDED; HOWEVER WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVAL. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD' 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. IT IS ALLEGED ON (B)(6) 2008, THE PT WAS IMPLANTED WITH A BARD MESH. MEDICAL RECORDS PROVIDED SHOW MESH INSERTION TO THE POSTERIOR COMPARTMENT OF THE VAGINAL FOR RE-ENHANCEMENT OF POSTERIOR REPAIR AND CYSTOSCOPY. THE OPERATIVE REPORT SHOWED THAT AFTER THE RECTOCELE WAS REDUCED SIGNIFICANTLY, A BARD MESH WAS PLACED ON TOP OF THIS REDUCED RECTOCELE AND WAS ANCHORED TO IT, THUS FURTHER REDUCING THE RECTOCELE. AT THIS TIME, THINNED OUT VAGINAL MUCOSA WAS TRIMMED AND REAPPROXIMATED THUS COMPLETING THE POSTERIOR REPAIR WITH MESH. ATTORNEY REPORT ALLEGED 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
    218820 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURI1105

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability