BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2983390 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01929
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR MESH RESECTION; UTEROSACRAL VAGINAL VAULT SUSPENSION; ANTERIOR COLPORRHAPHY; POSTERIOR COLPORRHAPHY; MESH- (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED. (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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01927. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/20/2017. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED URINARY TRACT INFECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VOIDING DYSFUNCTION, URGENCY, URINARY FREQUENCY, NOCTURIA, URGE INCONTINENCE, AND URINARY HESITANCY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 08/01/2017 PATIENT CODES: (B)(4) - VAGINAL PROLAPSE ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION EXCISION VAGINAL MESH SLING, HARVEST FASCIA LATA GRAFT FROM EXTREMITY, PLACE URETHRAL FASCIAL SLING, BILATERAL PARAVAGINAL REPAIR AND ANTERIOR COLPORRHAPHY ON (B)(6) 2016 BY DR. (B)(6) DUE TO STRESS URINARY INCONTINENCE, VAGINAL MESH EROSION, VAGINAL PROLAPSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND AN OBTURATOR 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85853 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 1354856

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention