BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 uphold (tm) lite with capio slim was used during a pelvic floor repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, there was a problem noted on the "needle." the failure mode is unclear, and attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.The event description may suggest that the capio carrier broke.Should additional relevant details become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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