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Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Obstruction/Occlusion (2422); No Code Available (3191)
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Event Date 08/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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Lot #, expiration date, manufacture date: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The voluntary user medwatch number is mw5086450.The device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this manufacturer report pertains to the second of two devices implanted during two different procedures.It was reported to boston scientific corporation that two upsylon devices were implanted for a partial hysterectomy and to correct uterine prolapse.According to the complainant, the first device was implanted on (b)(6) 2018.Reportedly, the patient had to undergo another procedure for mesh repair and revision due to the mesh collapsing and a second upsylon mesh was then implanted on (b)(6) 2018.However, she again had to undergo another surgery on (b)(6) 2019 to remove the broken mesh and to repair the blockage in her bladder due to the mesh.
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Search Alerts/Recalls
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