BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2869716 · Received December 12, 2012

    Report

    Report Number
    2210968-2012-07921
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PROLAPSE, VAGINAL EVERSION, AND MIXED INCONTINENCE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF AN ANTERIOR COLPORRHAPHY, PARAVAGINAL DEFECT REPAIR WITH MESH, POSTERIOR COLPORRHAPHY, SACROSPINOUS LIGAMENT FIXATION WITH MESH, AND ENTEROCELE REPAIR DURING MESH IMPLANTATION. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT AFTER IMPLANTATION THE PATIENT EXPERIENCED PAIN, INFECTION, BLEEDING, URINARY PROBLEMS, AND BOWEL PROBLEMS. THE PATIENT UNDERWENT ¿REPAIR OF ORIGINAL SURGERY¿ ON (B)(6) 2012 DUE TO ¿ORIGINAL MESH HAD RUPTURED¿. THE PATIENT UNDERWENT MESH REVISION/EXPLANTATION, ALONG WITH POSTERIOR COLPORRHAPHY, A GRADE II RECTOCELE REPAIR WITH SUTURE/NO MESH, CYSTOSCOPY, AND COAPTITE (REF 890-300 LOT: 1023872) ON (B)(6) 2012 DUE TO A SYMPTOMATIC RECTOCELE, A RECURRENT VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE. NO ADDITIONAL INFORMATION PROVIDED. (B)(4) - URINARY PROBLEMS; BOWEL PROBLEMS; ¿MESH RUPTURED¿; RECTOCELE; RECURRENT PROLAPSE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-07922 AND MEDWATCH 2210968-2012-07923. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURES ON (B)(6) 2007 AND (B)(6) 2012 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2978403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention