BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 1910458 · Received November 23, 2010

    Report

    Report Number
    2210968-2010-01575
    Event Type
    Injury
    Date Received
    November 23, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR, TENSION FREE VAGINAL TAPE/OBTURATOR.

    Additional Manufacturer Narrative · 1

    THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR: PRODUCT CODE PFRT01, BATCH 1358098, EXP DATE 09/30/2006, MFG DATE 11/29/2005; TENSION FREE VAGINAL TAPE/OBTURATOR: PRODUCT CODE 810081, BATCH 1361107, EXP DATE 10/31/2006, MFG DATE NI. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF VAGINAL GRAFT ON (B)(6) 2006 DUE TO CICATRIX OF VAGINA WITH RETRACTION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT EXAMINATION UNDER ANESTHESIA, URETHRAL DILATION AND CALIBRATION, CYSTOSCOPY, AND REMOVAL OF FOREIGN BODY ON (B)(6) 2008 DUE TO RECURRENT UTI, DYSPAREUNIA, AND VAGINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). FOLLOW-UP 02 WAS INITIALLY SUBMITTED VIA PAPER MEDWATCH AND MAILED TO THE FDA VIA CERTIFIED USPS ON 09/21/2015. THIS INFORMATION IS BEING RESUBMITTED EMDR AS IT IS UNKNOWN IF THE INFORMATION REACHED THE FDA DATABASE. THE INITIAL MEDWATCH AND SUPPLEMENTAL MEDWATCH REPORTS WERE SENT TO THE FDA VIA USPS. THIS SUPPLEMENTAL MEDWATCH REPORT IS BEING SUBMITTED ELECTRONICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SURGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE ON (B)(6) 2006 AND PELVIC FLOOR REPAIR MESH AND AN OBTURATOR SLING WERE IMPLANTED. THE PT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADD'L INFO WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXCISION OF THE SUBURETHRAL MESH SLING ON (B)(6)2009, AND HAD A MESH REMOVAL SURGERY ON (B)(6)2009.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF VAGINAL GRAFT ON (B)(6) 2006 DUE TO CICATRIX OF VAGINA WITH RETRACTION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT EXAMINATION UNDER ANESTHESIA, URETHRAL DILATION AND CALIBRATION, CYSTOSCOPY, AND REMOVAL OF FOREIGN BODY ON (B)(6) 2008 DUE TO RECURRENT UTI, DYSPAREUNIA, AND VAGINAL PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MESH PRODUCT (EWHU) MESH, SURGICAL FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention