BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2980912 · Received February 15, 2013

    Report

    Report Number
    1213643-2013-00048
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 31, 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
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THIS IS AN ELDERLY PATIENT WITH COMORBIDITIES OF HYPERTENSION AND FIBROMYALGIA. SHE HAS UNDERGONE MULTIPLE ABDOMINAL SURGERIES INCLUDING PREVIOUS BLADDER SURGERY WITH THE IMPLANT OF A NON-BARD VAGINAL SLING. THE MEDICAL RECORDS PROVIDED DO NOT COVER THE PERIOD PAST IMPLANT; THEREFORE AT THIS TIME THERE IS NO INDICATION THAT THE SOURCE OF THE ALLEGED POST OPERATIVE EVENTS WAS THE BARD FLAT MESH. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, THERE IS NO INDICATION THAT THE MESH HAS BEEN EXPLANTED. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2007 - BLADDER SURGERY WITH THE IMPLANT OF A NON-BARD VAGINAL SLING. (B)(6) 2010 - PATIENT UNDERWENT AN ANTERIOR COLPORRHAPHY WITH BARD FLAT MESH. THIS PROCEDURE WAS PERFORMED DUE TO A RECURRENT CYSTOCELE. THE FOLLOWING ALLEGATIONS WERE MADE BY THE PATIENT'S ATTORNEY: 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
    66715 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUF1494

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability