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The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The alleged event is most likely associated with possible procedural/surgical complications.The ifu currently addresses potential risks associated with surgically implantable materials which states the following: "the usual precautions associated with urological procedures should be followed: accepted surgical practice and precautions must be followed for the management of contaminated or infected wound sites, when the align¿ to urethral support system is used.Postoperative bleeding may occur in some patients and must be controlled prior to patient release.The implant procedure requires diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, and any viscera, during introducer needle passage.Proper placement of the mesh sling implant at mid-urethra requires that it lies flat with minimal or no tension under the urethra.The align¿ to urethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the align¿ to urethral support system.Patients should be advised that pregnancy following a mesh sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may reoccur.The safety and effectiveness of the align¿ to urethral support system implant procedure has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.Cystoscopy can be considered at the physician¿s discretion.Do not use the align¿ to urethral support system if the packaging is opened or damaged.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Adverse events: complications associated with the proper implantation of the align¿ to urethral support system may include, but are not limited to: postoperative hematoma, which may occur following the implant procedure.- temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant.Perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage.Transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion of the implant." 1750 = "l" 1928, 1994, 2330, 2348, 2371, 1908, 2328, 2415, 2194, 2134, 1754, 2091,1970, 2145, 2193,1820, 1983,2238, 3274,2607, 2275, 1871,1928, 2144,2475, 2119, 2564, 1880, 1914,1807, 2597, 2558,2519, 1941, 1815, 1966, 1979, 1860, 2361, 2240, 2102, 2137,2515, 1800,2467, 2452,= "nl".H11:section a through f - 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.H3 other text : the device was not returned.
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It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Product was used for therapeutic treatment.Per additional information received, the patient has experienced hypertension, ¿spells¿ (face and eyes feel puffy, top of mouth gets big and dentures don¿t fit, neck gets flushed-patient attributes to mesh), ¿jitters,¿ ¿apprehension,¿ anxiety, ¿burping and gas,¿ diagnosed with empty sella syndrome ((b)(6) 2011), multiple symptoms attributed by patient to mesh implant surgery on (b)(6) 2009 (¿eyes watering and squinty; feels uneven, which appears to be related to decreased balance; teeth feel foreign; lower back pain, constant pressure in face; back of head hurts; neck gets tight; patient gets cold [especially hands, which get cold, numb, and splotchy]; stomach hurts; dizziness (vertigo); lightheadedness; feeling drained and tired; constant runny nose; choking or gagging at times; stomach bloated; muscles in body will tighten and release; bruises easily; sour taste and bad breath; swelling that comes and goes; nausea; if she does not have a bowel movement when she feels the urge, she will develop tenesmus where her anal sphincter shuts down and she cannot go until the next day; occasional tinnitus; hurts to chew; feels short of breath when her muscles are tight; and pain rated 8/10 that keeps her from playing with grandchildren); polymyalgia etiology unknown, dyspepsia suggestive of gastroesophageal reflux disease, more frequent migraines (¿since mesh surgery¿), ¿vague-like symptoms like inability to feel her veins and they do not pop up like they used to,¿ whole-body weakness, cramps in lower extremities, bilateral essential tremor of upper extremities, cold intolerance, peripheral edema with her legs numb to her mid-calf and her hands numb just above her wrist in a stocking glove distribution, ¿feels wound-up on the inside,¿ fibromyalgia, peripheral neuropathy, smoker (quit (b)(6) 2013), unspecified myalgia and myositis, probable autoimmune disease, elevated catecholamines and metanephrines, diffuse pain, arthralgias, dysuria, pelvic pain, ¿sex impossible due to severe pain,¿ weight gain, hypercholesterolemia, mild urge, urinary frequency attributed to drinking a lot, urge urinary incontinence, anterior and posterior vaginal tenderness, ¿mesh bunched and contracted,¿ ¿mesh embedded in the vaginal wall in two spots at the apex where small buttonholes of the vagina had to be removed¿ ((b)(6) 2013), ¿cystocele stage 3,¿ stress incontinence status-post sling,¿ mesh eroded into urethra (nearly full-thickness perforation; (b)(6) 2013), ¿rectocele¿ ((b)(6) 2013), postoperative episode of orthostatic hypotension (40/20; (b)(6) 2013), postoperative nausea and vomiting ((b)(6) 2013), recurrent stage 3 cystocele ((b)(6) 2013), recurrent rectocele ((b)(6) 2014), mesh significantly bunched at the apex with a tight band ((b)(6) 2014), ¿few small vaginal perforations where mesh was very superficial¿ ((b)(6) 2014), chronic pelvic pain and vaginal area pain, severe frequency of urination, urgency, mesh erosion, recurrence of prolapse, urinary retention, suffered psychologically and emotionally, and loss of physical activity after undergoing an anterior and posterior repair with mesh and transobturator tape sling ((b)(6) 2009), a loss of consortium claim was also filed, patient ¿had suffered, may have suffered, or presently did suffer from¿ diverticulitis, erosion of pelvic, urethral, and bladder tissue; vaginal pain-muscle constrictions, chronic functional constipation requiring laxatives, removal of mesh sling, removal of anterior mesh kit, pubovaginal sling with allograft, anterior repair reinforced with allograft 6 x 8 cm using six-point fixation, washout, cystoscopy, and urethrorrhaphy ((b)(6) 2013); transvaginal removal of polypropylene mesh implant, posterior repair using plication technique, irrigation and washout protocol ((b)(6) 2014); transurethral injection ((b)(6) 2014).Per additional information received, the patient has experienced drainage, rectocele/cystocele stage three (prolapse), painful mesh, pelvic pain, constipation, migraines, weakness, unable to have sex, pain with sex, weight gain, hypertension, hypercholesterolemia, frequency, urgency, urge urinary incontinence, urethral perforation/erosion/buttonholes, urethral defect, hypotension, dehydration, flushing, lightheaded (dizziness), blood loss, bloody vaginal output, dysuria, hematuria, mesh bunched at apex, tight band, vaginal wall perforations and nonsurgical and additional surgical interventions.Per additional information received via medical records on (b)(6) 2017, the patient has experienced neurological issues, constipation, weakness, bowel irritation, lower abdominal symptoms, pain with sex, disability due to fmr, migraines since pop surgery, never returned to work, urge urinary incontinence, recurrent rectocele, recurrent cystocele, urethral pain, pelvic pain, stress urinary incontinence, mesh erosion into the urethra, vaginal pain, rectal pain, intrinsic sphincter deficiency, and has required three surgical interventions consisting of two explant and revision surgeries on (b)(6) 2013 and (b)(6) 2014, requiring fascia tutoplast and floseal placement during (b)(6) 2013 revision and an injection of macroplastique on (b)(6) 2014.Per additional information received via medical records on (b)(6) 2023, the patient experienced hyperparathyroidism, dysphagia, facial flushing, fibromyalgia, diffuse muscle spasms, numbness in hand and feet, upper and lower abdominal pain, chronic narcotics, migraines, peripheral neuropathy, monoclonal gammopathy, dyslipidemia, poor bowel control, nausea, emesis, high normal calcium level, blood in stool, hematemesis, dysphagia, icterus, nausea/vomiting, change in bowel habits, loose stools, dysuria, urinary frequency, incontinence, nocturia, change in gait or difficulty walking, easy bruising, excessive bleeding, recurrent laryngeal nerve injury, myositis, legs swelling, muscle aches, hypertension, depression, essential tremor, gerd, hypotensive episode, hiatal hernia esophageal dilatation, catecholamine levels increased, elevated metanephrines, left posterior scalp mass, autoimmune thyroid disease, clinical concern for pheochromocytoma, bloating, elevated crp, scalp cysts, neurological issues, multiple sclerosis, bowel irritation, tremor, blurry vision, sore throat, unspecified vitamin ¿ d deficiency, cystocele, rectocele, constipation, stress urinary incontinence, acne vulgaris, complications of genitourinary device, painful intercourse, weight gain and htn, hypercholesterolemia, urethral perforation or erosion, urinary incontinence, urinary retention, injury to sciatic nerve or pelvic nerves such as the pudendal nerve, graft complication, recurrent rectocele, menopausal syndrome, poor bowel control, positive ana, musculoskeletal pain, burping and passing a lot of gas, empty sella syndrome, diaphoresis, palpitations, arthralgias, jitters, apprehension, anxiety, mesh erosion and the required nonsurgical and additional surgical interventions.
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