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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: precautions the usual precautions associated with urological procedures should be followed: - based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for the implant procedure.Additional consideration should be given to use of the implant in patients with a compromised immune system, any condition that would compromise healing, or any patient with a history of prior abdominal or pelvic surgeries.Consideration should also be given to the ability of the patient to tolerate the surgical procedure.- 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 structures and care to avoid puncture of large vessels, nerves, bladder, bowel, urethra and any viscera, during introducer passage.- due to anatomical distortion that can be caused by pelvic organ prolapse, if the patient requires cystocele repair, it should be performed prior to the implantation of the sub-urethral sling.- proper placement of the sling implant at the mid-urethra requires that it lie flat with minimal or no tension under the urethra.- the align® to urethral support system is intended as a single-use device.Do not re-sterilize any portion of the align® to urethral support system.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.- patients should be advised that pregnancy following a sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may recur.- 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.- check the integrity of the packaging before use.Do not use the align® to urethral support system if the packaging is opened or damaged.- as for any implantable material, it is recommended to open the package at the time of implantation.- post-operatively the patient should be advised to refrain from heavy lifting, exercise (e.G.Cycling, jogging) and/or intercourse until the physician determines it is suitable for the patient to return to normal activities.Adverse events complications associated with the proper implantation of the align® to urethral support system may include, but are not limited to: - postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.- urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.- perforations or lacerations of vessels, nerves, bladder, bowel, urethra, or any viscera, which may occur during the implantation procedure.- irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.- extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.- inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence.1930, 1928, 2120, 2119="l" 2144, 2361, 2153, 2034, 2238, 1858, 2564, 2665, 2467, 1849, 2560, 2092="nl" h11:section a through f - the information provided by bd 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 bd.H3 other text : no sample received.
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The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced incontinence, pain, infection, unspecified urinary problems, recurrence, dyspareunia, unspecified neuromuscular problems and additional surgical intervention.Per additional information received, the patient has experienced vaginal bleeding resulting anemia, shortness of breath and palpitations, 2 postoperative emergency room visits after discharge for fever of unspecified cause, myalgia and dysuria, urinary urgency, pelvic pain, worsening persistent stress urinary incontinence requiring 4 pads/day, abdominal bloating, dyspareunia, bilateral pelvic nerve pain with numbness and pain in her legs, pelvic floor physical therapy x17 sessions, placement of a suburethral autologous fascial sling on 8/22/16 with postoperative urinary retention requiring intermittent self-catheterization x3 days, and urinary tract infection, pain, infection, urinary problems, recurrent, dyspareunia, and neuromuscular problems.Per additional information received, the patient has experienced vaginal bleeding resulting anemia, shortness of breath and palpitations, 2 postoperative emergency room visits after discharge for fever of unspecified cause, myalgia and dysuria, urinary urgency, pelvic pain, worsening persistent stress urinary incontinence requiring 4 pads/day, abdominal bloating, dyspareunia, bilateral pelvic nerve pain with numbness and pain in her legs, pelvic floor physical therapy x17 sessions, placement of a suburethral autologous fascial sling on 8/22/16 with postoperative urinary retention requiring intermittent self-catheterization x3 days, and urinary tract infection.Per ppf, the patient alleges she suffered pain, infection, urinary problems, recurrent, dyspareunia, and neuromuscular problems.Per additional information received on via sharepoint march 18, 2019, the patient alleged that she experienced sciatic nerve pain, nerve pain in the inner thighs, emotional trauma due to severe leaking, painful intercourse (dyspareunia), weakness in legs, pelvic floor pain and tightness, inability to work, pelvic floor inflammation, bladder issues, possible infection, loss of consortium, mini laparotomy, autologous fascial sling, cystoscopy, attempted/unsuccessful mesh removal, cystocele, recurring vaginal pain tightness, stabbing, aching, and urinary incontinence.The patient allegedly required non-surgical interventions and a surgical intervention.Per additional information received via medical records on november 14, 2023, the patient has experienced infection, cystocele, dyspareunia, pelvic trauma, recurrent vaginal pain, fever, myalgia, palpitations, anemia, unspecified inflammatory spondylopathy (lumbar region), family history of malignant neoplasm of prostate, dizziness, asthma, gastroesophageal reflux disease, hiatal hernia, urinary incontinence, neuromuscular problems, pelvic floor tightness, sciatic nerve pain, pelvic inflammation, recurrent stress urinary incontinence, anxiety, neuralgia, chronic pelvic cellulitis, erosion of vaginal mesh, pelvic pain, vaginal pain, muscular groin pain, leg pain, foreign material in vagina, hematuria, dysuria, vomiting, chills, nausea, myofascial pain dysfunction syndrome, pelvic floor dysfunction, depression, pain with intercourse, urinary urgency, sacroiliac joint dysfunction of both sides, hot flashes, lumbar radiculitis, displacement lumbar disc, muscle spasm, bilateral shoulder pain, adhesive capsulitis of left shoulder, pelvic floor dysfunction, lumbar degenerative disc disease, myofascial pain, right renal mass, fatigue, raynaud¿s disease without gangrene and required additional surgical and non-surgical treatments.
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