BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2881979 · Received December 20, 2012

    Report

    Report Number
    2210968-2012-08151
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. THE PATIENT HAS A HISTORY OF BLADDER DYSFUNCTION AT MESH WITH PERFORATION OF THE BLADDER RESULTING IN 6-8 CYSTOSCOPIES FOR BLADDER STONES AND REMOVAL OF FOREIGN BODIES FROM THE BLADDER. THE PATIENT UNDERWENT MESH REMOVAL AND URETHRAL CAUTERIZATION ON (B)(6) 2005. THE PATIENT UNDERWENT EXPLORATION AND EXCISION OF WOUND SEROMA ON (B)(6) 2005. THE PATIENT UNDERWENT CYSTOSCOPY, REMOVAL OF BLADDER STONE, LASER ABLATION AND REMOVAL OF ERODED MESH ON (B)(6) 2007. THE PATIENT¿S LAST CYSTOSCOPY IN (B)(6) 2012 WAS DESCRIBED AS NORMAL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT LOWER QUADRANT PELVIC PAIN, PAINFUL SEX, AND URGENCY ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH AND PLACEMENT OF RIGHT DOUBLE J STENT AND OPEN CYSTOTOMY ON (B)(6) 2003 .NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, ORGAN PERFORATION, RECURRENCE, BLEEDING AND MULTIPLE BLADDER STONES. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF RESIDUAL MESH WITH STONE ENCRUSTATION AND BLADDER LESION ON (B)(6) 2010, A CYSTOSCOPY, PLACEMENT OF CYSTOTOMY TROCARS IN TO THE BLADDER AND REMOVAL OF RESIDUAL MESH ON (B)(6) 2010 AND A CYSTOSCOPY, LASER ABLATION OF RETAINED MESH, EXTRACTION OF BLADDER STONE AND FULGURATION OF BLADDER ON (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENCY, NOCTURIA, HEMATURIA AND INCONTINENCE. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE ADDITIONAL 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 OTN ETHICON INC NA 1039452

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention