BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3202038 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11891
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    July 1, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT VAGINAL/PARAVAGINAL REPAIR DUE TO STRESS URINARY INCONTINENCE WITH INTRINISIC SPHINCTER DYSFUNCTION AND ANTERIOR WALL PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT MESH EXCISIONS ON: (B)(6) 2006, (B)(6) 2008, (B)(6) 2008. IT WAS REPORTED, THE PATIENT UNDERWENT URETHROLYIS AND PLACEMENT OF AUTOLOGOUS PUBOVAGINAL SLING (B)(6) 2010, THEN UNDERWENT EXCISION OF VASCULAR SINUS TRACT WITH FOREIGN BODY ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT INSTILLATION OF URETHRAL CONTIGEN AND VAGINAL EXAM UNDER ANESTHESIA ON (B)(6) 2009 DUE TO INTRINSIC SPHINCTERIC DEFICIENCY. IT WAS REPORTED THAT PATIENT UNDERWENT INSERTION OF URETHRAL CONTIGEN AND FULGURATION OF VAGINAL LESION ON (B)(6) 2009 DUE TO INTRINSIC SPHINCTERIC DEFICIENCY AND VAGINAL BLEEDING. IT WAS REPORTED THAT PATIENT UNDERWENT INJECTION OF BLADDER BOTOX AND EXCHANGE OF SUPRAPUBIC CATHETER ON (B)(6) 2012 DUE TO NEUROGENIC BLADDER. IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY AND BLADDER BOTOX INJECTIONS ON (B)(6) 2013 DUE TO OVERACTIVE BLADDER WITH URGE INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL ANTERIOR AND APICAL PROLAPSE AND INTRINSIC SPHINCTERIC DEFICIENCY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO OTHER CLARIFYING INFORMATION PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302290 GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. 1357310

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention