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
Erosion (1750); Fatigue (1849); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Disability (2371); Prolapse (2475); Dyspareunia (4505); 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).No sample received.
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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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Manufacturer Narrative
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Correction: mdr date of awareness.
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Manufacturer Narrative
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1750,2120, 2475 = "l".1706, 1908, 2560 = "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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Per additional information received via medical records on 30mar2022, the patient has experienced mesh erosion, chronic pain, vaginal bleeding, urinary tract infections, lethargic, anemia, diverticulitis, dyspareunia, hypertension, uterine prolapse and required additional surgical and non-surgical interventions.
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Manufacturer Narrative
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1932 = "l" 1888, 1928, 1849= "nl" correction: g.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 (b)(6) 2024, the patient had experienced mesh erosion, vaginal bleeding, atrophic vaginitis, urinary tract infection, urinary incontinence, anemia, uterine prolapse, cystocele, diverticulitis, dyspareunia, hypertension, recurrent or chronic vaginal or bladder infections, lower back pain, malaise and fatigue and required additional surgical non-surgical treatment.
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Search Alerts/Recalls
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