BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2973305 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01534
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND URETHRAL HYPERMOBILITY AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ACUTE CYSTITIS, PAIN IN VAGINA AND ABDOMEN, PAINFUL INTERCOURSE AND RECURRENT URINARY INCONTINENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION /REMOVAL OF SUBURETHRAL SLING ON (B)(6) 2014 AND (B)(6) 2015. IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, URINARY TRACT INFECTIONS, URINARY RETENTION AND FECAL INCONTINENCE RESULTING FROM BOTOX AND TRIGGER POINT INJECTIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    DETAILS: IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, URINARY TRACT INFECTIONS, URINARY RETENTION AND FECAL INCONTINENCE RESULTING FROM BOTOX AND TRIGGER POINT INJECTIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION /REMOVAL OF SUBURETHRAL SLING ON (B)(6) 2014 AND (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75805 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 1359458

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention