BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3170078 · Received June 5, 2013

    Report

    Report Number
    1213643-2013-00248
    Event Type
    Injury
    Date Received
    June 5, 2013
    Report Date
    June 13, 2013
    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
    CO, 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 PARTIAL OPERATIVE REPORT INCLUDED WITH THE ATTORNEY'S REPORT INDICATES THAT THE PT HAD A RECURRENT VAULT PROLAPSE AND SEVERE URINARY INCONTINENCE AND UNDERWENT A PROCEDURE IN WHICH A BARD FLAT MESH WAS IMPLANTED. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND THE MEDICAL RECORDS PROVIDED INCLUDED ONLY PAGE 1 OF THE IMPLANT OPERATIVE REPORT. WITHOUT A LOT NUMBER A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. THIS MDR INCLUDES ALL PT, EVENT, AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 1996 - PT HAD A RECURRENT VAULT PROLAPSE AND SEVERE STRESS URINARY INCONTINENCE. SHE UNDERWENT EXPLORATORY LAPAROTOMY, RIGHT SALPINGO-OOPHORECTOMY, VAGINAL VAULT SUSPENSION TO THE SACRAL PROMONTORY WITH A MARLEX MESH, PARAVAGINAL REPAIR VIA THE ABDOMINAL APPROACH, ANTERIOR AND POSTERIOR REPAIR. THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: IT IS ALLEGED ON (B)(6) 1996, THE PT WAS IMPLANTED WITH MARLEX MESH. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADDITIONAL MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249524 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability