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Catalog Number 486100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Micturition Urgency (1871); Blood Loss (2597)
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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 vaginal mesh erosion, exposure, bacterial vaginosis, bleeding, vaginal discharge, bulging sensation, occasional urgency, rare urinary urge incontinence, stage iii + cervical elongation.She has required nonsurgical interventions and one surgical intervention to remove vaginal sling or mesh.
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Search Alerts/Recalls
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