BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502120 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Swelling (2091); Injury (2348)
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Event Date 09/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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The event date was approximated to (b)(6) 2019, as it was reported that the patient experienced tongue and lip swelling later in (b)(6) 2019.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The implant date was approximated to (b)(6) 2019 as it was reported that the device was implanted early in (b)(6) 2019.(b)(4).The complainant indicated that the device is implanted and will not 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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It was reported to boston scientific corporation that an advantage fit blue system was implanted during a procedure performed on early in (b)(6) 2019.According to the complainant, later in (b)(6) 2019, the patient experienced tongue and lip swelling and stayed in the intensive care unit (icu) for a while.Reportedly, the patient also presented with other medical issues.
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