BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2982460 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01871
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT A REPLIFORM PUBOVAGINAL SLING LACING PROCEDURE ON (B)(6) 2006.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE, CYSTOCELE AND RECTOCELE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL/REVISION ON (B)(6) 2006.

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ADHESION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A&P COLPORRHAPHY. IT WAS REPORTED THAT PATIENT ALSO UNDERWENT URETHROLYSIS, COMBINED A&P COLPORRHAPHY, BARD PELVICOL IMPLANT FOR PROSTHETIC SUPPORT OF VAGINAL WALL ON (B)(6) 2006 BY DR. (B)(6) AT (B)(6). (PER IMPLANT RECORD)

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL VAULT PROLAPSE AND URINARY RETENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, BLADDER OUTLET OBSTRUCTION, URINARY TRACT INFECTION, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING, NOCTURIA, AND URGENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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 MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A&P COLPORRHAPHY. IT WAS REPORTED THAT PATIENT ALSO UNDERWENT URETHROLYSIS, COMBINED A&P COLPORRHAPHY, BARD PELVICOL IMPLANT FOR PROSTHETIC SUPPORT OF VAGINAL WALL ON (B)(6) 2006 BY DR. (B)(6) AT (B)(6). (PER IMPLANT RECORD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87512 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 1257287

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention