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Catalog Number 486101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Incontinence (1928); Pain (1994); Urticaria (2278); Distress (2329); Discomfort (2330); Injury (2348); Prolapse (2475)
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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 injury, pain, disability and impairment.Per additional information received the patient has experienced pain with intercourse, prolapse of vaginal vault after hysterectomy, pain due to genitourinary prosthetic device, enfolding of mesh, tight band and arch of mesh material spanning the anterior compartment midway in the vagina, obstructing the vaginal apex, pelvic scarring, and required nonsurgical and one surgical intervention.
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Manufacturer Narrative
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2061,2564= "l".2422,2519,2371,2329,2330,1695,1928,2278 = "nl".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 experienced severe painful intercourse, emotional distress, discomfort, adhesions, urinary incontinence, urticaria (chronic hives) and required additional surgical and non- surgical treatments.
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Search Alerts/Recalls
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