BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3072906 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04306
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    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). IT WAS REPORTED THAT THE PATIENT HAD OPEN LEFT NEOCYSTOSTOMY, BLADDER PSOAS HITCH, DOUBLE J STENT PLACEMENT ON LEFT URETER, AND CYSTOSCOPY WITH LEFT RETROGRADE PYELOGRAM ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2005 DUE TO STRESS URINARY INCONTINENCE. FOLLOWING MESH INSERTION, THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, DYSPAREUNIA AND NEUROMUSCULAR PROBLEMS . IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY, RIGHT OVARIAN CYSTECTOMY, FULGURATION OF ENDOMETRIOTIC IMPLANTS, HYSTEROSCOPY, D&C, AND ENDOMETRIAL POLYPECTOMY ON (B)(6) 2010 DUE TO MENORRHAGIA, DYSMENORRHEA, CHRONIC PELVIC PAIN, ENDOMETRIOSIS, RIGHT OVARIAN CYST AND ENDOMETRIAL POLYPS AND A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2011 DUE TO PELVIC PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTION, MIXED FEMALE INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY; HYDRO DISTENSION AND BLADDER INSTILLATION DUE TO BLADDER PAIN AND INTERSTITIAL CYSTITIS ON (B)(6) 2010 BY DR. (B)(6) MD AT THE (B)(6). (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) 2005 AND MESH WAS IMPLANTED. 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.

    Description of Event or Problem · 1

    DETAILS: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTION, MIXED FEMALE INCONTINENCE. DETAILS: IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY; HYDRO DISTENSION AND BLADDER INSTILLATION DUE TO BLADDER PAIN AND INTERSTITIAL CYSTITIS ON (B)(6) 2010 BY DR. (B)(6) MD AT THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173954 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 900700

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention