C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
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Catalog Number 486101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Asthma (1726); Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Distress (2329); Injury (2348); Disability (2371); Prolapse (2475); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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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It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, injury, disability, and impairment.
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Event Description
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N/a.
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Manufacturer Narrative
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Correction: mdr date of awareness.
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Event Description
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Per additional information received on (b)(6) 2021, the patient has experienced pain, urinary tract infections, mesh erosion, pelvic and groin pain, emotional and mental distress, stabbing pain in vagina, cystocele, enterocele, bladder infections, urinary incontinence, uterine prolapse, vaginal dryness, overactive bladder, nocturia, vaginal prolapse, bulge sensation, grade 1-2 distal rectocele, grade 2 vault prolapse, urinary frequency and required additional surgical and non-surgical interventions.
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Manufacturer Narrative
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1750, 2120, 1930, 2475="l" 2329, 1928, 2275="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.
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Manufacturer Narrative
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1685="l".2564, 2519 ="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.
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Event Description
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As per additional information received via medical records on 08jan2024, the patient had experienced vaginal pain, stabbing injuries in the vagina, urinary tract infection, mesh erosion, pelvic and groin pain, emotional and mental distress, cystocele, enterocele, bladder infections, urinary incontinence, uterine prolapse, vaginal dryness, overactive bladder allergies, mild asthma and required additional surgical and non- surgical treatment.
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Search Alerts/Recalls
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