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 10/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device 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 uphold lite with capio slim was used during a pelvic floor prolapse repair performed on (b)(6) 2017.According to the complainant, during the procedure, the capio cage (groove on top of the capio slim) was almost loose and the needle detached from the suture.The procedure was completed with another uphold¿ lite.The condition of the patient post procedure was stable.
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Search Alerts/Recalls
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