C.R. BARD, INC. (COVINGTON) -1018233 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
Erosion (1750); Injury (2348); Intermenstrual Bleeding (2665)
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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: ¿potential adverse reactions are those typically associated with surgically implantable materials, including 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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The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced vaginal bleeding, erosion of vaginal mesh, excision of vaginal mesh, chronic inflammation, vaginal mesh exposure, postcoital bleeding, recurrent rectocele, cystocele, and enterocele, excision of posterior vaginal mesh, anterior and posterior enterocele repair, partial vaginectomy, extraperitoneal colpopexy, and required two surgical interventions.
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Search Alerts/Recalls
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