BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint device is not expected to 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 was used during an anterior repair procedure performed on (b)(6) 2017.According to the complainant, during preparation, when the box was opened, it was noticed that the package seal was torn.The procedure was completed with another uphold lite.There were no patient complications 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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Search Alerts/Recalls
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