C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR; AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR
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Catalog Number 486201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Erosion (1750); Diarrhea (1811); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Arthralgia (2355); Disability (2371); Prolapse (2475); Hematuria (2558); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577)
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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: hematoma, seroma, mucosal or visceral erosion, infection, inflammation, sensitization, dyspareunia, scarification and contraction, fistula formation, extrusion and recurrence of vaginal wall prolapse.Perforations or lacerations of vessels, nerves, bladder, bowel, rectum, or any viscera may occur during needle passage.(b)(4).
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Event Description
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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 pain, suffering, disability, impairment, loss of enjoyment of life, inability to engage in chosen and necessary activities and/or economic damages.
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Event Description
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Per additional information received on 04jun2021, the patient experienced vaginal mesh erosion, pain, dyspareunia, urge incontinence, urinary frequency, nocturia, bleeding, cystocele, enterocele, rectocele, recurrent vaginal pain, urinary incontinence, uterine prolapse, vaginal atrophy, incomplete emptying, frequent urinary tract infections, hematuria, kidney stones, kidney problems, vaginal pressure, constipation, diarrhea, autoimmune disease, leg swelling, arthralgias and required additional surgical and non-surgical interventions.
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Manufacturer Narrative
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1750, 2475, 2120="l" 2275, 1888, 1685, 2558, 3274="nl".
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Search Alerts/Recalls
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