BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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(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¿ lite device was used during a pelvic floor repair procedure performed on (b)(6) 2017.According to the complainant, ¿there was a defect at the junction of the needle and the suture.¿ this is most likely the needle detached from the suture.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.
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Search Alerts/Recalls
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