BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3952012 · Received July 15, 2014

    Report

    Report Number
    1213643-2014-00231
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    July 17, 2012
    Report Date
    June 18, 2014
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVALUATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED OFF A REVIEW OF THE PATIENT'S MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2008: THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY, BURCH COLPOSUSPENSION, ABDOMINAL REPAIR OF CYSTOCELE, CYSTOSCOPY, POSTERIOR COLPORRHAPHY (SPATE APPROACH PER VAGINA), AN VAGINAL REPAIR OF PERINEOCELE WITH IMPLANTATION OF A BARD FLAT MESH. ON (B)(6) 2012: DUE TO POST-OP COMPLICATIONS, THE PATIENT UNDERWENT BOTOX INJECTION IN PELVIC FLOOD MUSCLES AND BILATERAL PUDENDAL NERVE BLOCKS ROBOTIC ASSISTED LAPAROSCOPY, LYSIS OF ADHESIONS, MCCALL CULDOPLASTY, CYSTOSCOPY AND REMOVAL OF THE BARD FLAT MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413000 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURG0884

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention