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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: "complications associated with the proper implantation of the avaulta solo® synthetic support may include, but are not limited to those typically associated with surgically implantable materials, including: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction and too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, 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 vaginal wall prolapse.Urinary incontinence (stress and urge)." (b)(4).
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Event Description
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The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Per additional information received, the patient has experienced grade1 cystocele, questionable grade 1 rectocele, urinary incontinence, cystocele, soreness area, incontinence, sphincter dysfunction, urgency, frequency urination, painful intercourse, depression anxiety, fever, thalassemia, mesh erosion.The patient additionally required non-surgical interventions.
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Search Alerts/Recalls
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