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 Consequences Or Impact To Patient (2199)
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Event Date 12/06/2016 |
Event Type
malfunction
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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.However, the complainant reported that the device was not expired.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.(b)(4).
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Associated mfr report #3005099803-2016-03933 pertains to the other device.It was reported to boston scientific corporation that an uphold¿ lite was used during an anterior repair procedure on (b)(6) 2016.According to the complaint, during the procedure, the needle detached from the suture and it was found inside the capio cage.The procedure was completed with a different device.There was no any patient complication reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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