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Catalog Number 486101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Scarring (2061); Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative
The sample was not returned. The lot number is unk; therefore, the device history record could not be reviewed. The instructions for use which accompanies all device currently address potential risks associated with surgically implanted materials. (b)(4). "lawyer-filed report - (b)(6). ".
Event Description
(b)(4). It was reported in the pt's medical records that as a result of having the product implanted, the pt has experienced post-operative pain (noted on (b)(6) 2008 following surgery on (b)(6) 2008), perineal descent syndrome (status-post surgery on (b)(6) 2008), pds suture or corner of mesh that was barely palpable just inside the introitus on the left (status-post surgery on (b)(6) 2008), dyspareunia, mesh extrusion (5mm corner of mesh and pds suture very close to the introitus, status-post surgery on (b)(6) 2008), tight band at the introitus (tightness across the vestibule), bulky uterus, menorrhagia with clots, severe dysmenorrhea, severe menstrual cramps, "felt that her anatomy had been distorted and was concerned with the appearance," had to alter position to urinate so that the urine did not collect in the posterior vagina, narrowed introitus, bothersome posterior labia scar, vaginal mesh protrusion (felt by the pt's partner), constricting band at the base of the labia majora, perineal scarring, 2-3 mm hard mass in the posterior fourchette area (pathology indicated mild inflammation, hyperplasia, and focal epidermidization without dysplasia or malignancy), irritation and wetness (unspecified - presumed perineal), persistent mild edema (unspecified - presumed perineal), areas of tenderness over the posterior vaginal wall in the area of the mesh, right lower quadrant abdominal/pelvic pain, vaginal discharge, intermittent tenderness just below the insertion of the left adductor tendon which radiated to the medial thigh, bleeding (unspecified - presumed from misoprostol), misoprostol for pregnancy termination ((b)(6) 2009), chronic vaginal pain, fibrosis at the entrance to the vagina, moderate scarring and unevenness in the vagina, nerve pain that radiated down one thigh, firm mid-lower posterior vaginal wall (mesh with rigidity and tenderness), difficulty emptying bladder frequent urination in small amount, difficulty in starting urine stream, slow urine stream, dysuria, had to hurry to empty her bladder when full, recurrent urinary tract infections, urinary obstruction, stress incontinence, significant tissue wedge at the hymenal ring (tore with intercourse), pain related to a surgical mesh system, difficulty evacuating her stool (needed to splint, especially on the left side where her pain was), diarrhea, pelvic pain throughout her pelvic floor, vaginal band of scarring along the perineal body on the left and at the ischial spines, lateral cystocele, vaginal prolapse after hysterectomy, stage 1 rectocele (on (b)(6) 2010 examination), stage 2 anterior wall prolapse (on (b)(6) 2010 examination), kinking of the uvj (presumed - ureterovesical junction), stage 2 vault prolapse (on (b)(6) 2010 examination), perineal rectocele, significant banding and tenderness where the avaulta mesh arms came in at the perineal body and proximally to the ischial spine, hypertonic pelvic floor, vaginal discomfort with minimal itching, mesh exposure (on (b)(6) 2010 examination), tender and scarred perineum (on (b)(6) 2010 examination), posterior fourchette skin band (on (b)(6) 2010 examination), posterior band-like thickness (on (b)(6) 2010 examination), grade 1 cystocele (on (b)(6) 2010 examination), posterior vaginal wall scarring (on (b)(6) 2010 examination), questionable mesh banding at the lower aspect (on (b)(6) 2010 examination), stress incontinence (on (b)(6) 2010 exam), moderate voiding dysfunction (on (b)(6) 2010 exam), male dyspareunia, inflammation of mesh (on (b)(6) 2010 exam), sense of incomplete rectal emptying, superficial separation of the perineum with 2 visible sutures (status-post surgery on (b)(6) 2010), bleeding and foul odor at the surgery site (status-post surgery on (b)(6) 2010), perineal inflammation (status-post surgery on (b)(6) 2010), infected postoperative vaginal wound (status-post surgery on (b)(6) 2010), mild wound dehiscence (status-post surgery on (b)(6) 2010), pelvic phleboliths, "something" on the left side between her vagina and the left leg that hurts terribly (status-post surgery on (b)(6) 2010), possible obturator nerve irritation, left leg and pelvic radiculitis, neuropathy, extensive pelvic venous varicosities, pain associated with possible sciatic distribution on the left side, pelvic floor dysfunction, low back pain, decreased left lower extremity strength, pain/decreased tolerance (sitting, bending, and standing), tingling of left toes and foot, chronic leg pain, spasms (legs, toes, hip adductors), numbness of left anterior thigh, aching/throbbing of left posterior perineum, less than six hour sleep per night due to pain, involuntary muscle contraction/cramping of the left calf, left lower extremity pain was consistent with myofascial in nature, abnormal sensation down the back of her left lower extremity and medial foot, multiple internal and external pelvic myofascial restrictions, patient could feel "a piece of plastic" in the posterior lateral aspect of her distal vagina, moderate tenderness on the left with deep palpation of the levators, nodularity over the posterior vagina, roughness of the vaginal epithelium, persistent pain over the adductor region (likely adductor myalgia and tendonitis), referred neuropathic pain over the left medial thigh and lower extremity, squamous inclusion cyst (on vaginal skin excision performed on (b)(6) 2010), levator myalgia, urgency, overactive bladder, bladder atony, pbs (presumed - painful bladder syndrome), mild pricking discomfort of the lower abdomen, poor sustained contractility (on urodynamic evaluation), prolonged voiding with significant strain, grade 1 lateral cystocele (per dr. On (b)(6) 2011), grade 0 rectocele (per dr. On (b)(6) 2011), grade 0 prolapse (per dr. On (b)(6) 2011), ridge horizontally across the perineum which was palpable 4-5 mm under the perineal skin (per dr. On (b)(6) 2011), excess skin on the posterior vaginal wall (per dr. On (b)(6) 2011), vaginal pain at the point of the arms into the levator ani (per dr. On (b)(6) 2011), vaginal stricture (per dr. On (b)(6) 2011), vaginal/vulvar scar (per dr on (b)(6) 2011), "something" under the posterior vaginal epithelium with a definite shape that produced pain when palpated (per dr on (b)(6) 2011), horizontal tension underneath the perineal skin which was more obvious on the right side, entrapment of the left obturator nerve (most likely, per dr (b)(6)), bilateral pelvic floor muscle spasm, lower quadrant tenderness with positive carnett's sign, significant tenderness which was consistent with obturator nerve neuralgia and possible injury with the mesh, pelvic floor tension myalgia, retained avaulta mesh (per (b)(6) 2011 operative report), retained transobturator mid-urethral sling mesh (per (b)(6) 2011 operative report), chronic inflammatory and foreign body giant-cell reaction of the excised anterior and posterior mesh-entrapped material (per (b)(6) 2011 pathology report), medical problems left her depressed and anxious ("felt wronged"), "still having pain" (location not specified in the record; per the office visits on (b)(6) 2011), burning in the left hip that radiated down to the foot (per the office visit on (b)(6) 2011), felt that mesh on the right side of her vagina had extruded, pain with intercourse and partner dyspareunia in a very specific area (per office visit of (b)(6) 2011), stress urinary incontinence (per office visit of (b)(6) 2011), retained vaginal mesh (per operative report on (b)(6) 2011), and psychological and emotional suffering who underwent unspecified surgical procedures (presumed - mesh and pds suture excisions from the description of the procedure on (b)(6) 2008), an unspecified revision (operative report not included in the records provided), perineoplasty, revision and partial removal of vaginal mesh with rectocele repair, vaginal mesh revision, excision of vaginal mesh, robotic-assisted laparoscopy x 2, excision of pelvic mesh portion, obturator neurolysis, placement of platelet-rich graft on the obturator nerve, encasement of the obturator nerve in neuragen, cystoscopy x 2, proctoscopy, botox injection into the pelvic floor muscles x 2, bilateral pudendal nerve block x 2, excision of a vaginal mass, burch procedure, and a paravaginal defect repair.
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Manufacturer (Section D)
covington GA
Manufacturer (Section G)
8195 industrial blvd.
covington GA 30014
Manufacturer Contact
angela robinson
8195 industrial blvd
covington, GA 30014
MDR Report Key3322429
MDR Text Key11135962
Report Number1018233-2013-06797
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Reporter Occupation Attorney
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2013
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number486101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received10/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/27/2013 Patient Sequence Number: 1