BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 3203744 · Received June 26, 2013

    Report

    Report Number
    1213643-2013-00275
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    April 12, 2011
    Report Date
    June 17, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033814
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. BASED ON THE REVIEW OF THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY, THE PT UNDERWENT A PELVIC REPAIR PROCEDURE ON (B)(6) 2006. FOUR AND A HALF YRS LATER THE PT HAD RECURRENCE OF HER STRESS URINARY INCONTINENCE, ALONG WITH DYSPAREUNIA, CYSTOCELE, INTERSTITIAL CYSTITIS AND LEFT MONS NEOPLASM. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO. 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 ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF THE PT'S MEDICAL RECORDS WHICH WERE PROVIDED BY THE PT'S ATTORNEY. ON (B)(6) 2006 - PT UNDERWENT LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, HIGH UTEROSACRAL SUSPENSION, CYSTOSCOPY. DURING THE PROCEDURE THE PT WAS IMPLANTED WITH MULTIPLE PELVIC DEVICES INCLUDING A BARD SOFT MESH FOR UTERINE PROLAPSE AND URINARY INCONTINENCE. ON (B)(6) 2011 - PT UNDERWENT, VAGINAL RETROPUBIC SLING, ANTERIOR VAGINAL REPAIR, EXCISION OF 3 CM LEFT MONS REGION, CYSTOSCOPY WITH HYDRODISTENSION AND INSERTION OF SUPRAPUBIC CATHETER WITH REMOVAL OF ALL PREVIOUSLY PLACED PELVIC DEVICES INCLUDING THE BARD SOFT MESH, AS WELL AS PLACEMENT OF A NON-BARD IMPLANT. THE ATTORNEYS REPORT ALLEGED ADDITIONAL MEDICAL/SURGICAL TREATMENT, NERVE DAMAGE, PERMANENT INJURY, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290642 BARD SOFT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA DAQE0006

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability