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Model Number M0068318200 |
Device Problem
Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The lot number does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined, however, it was reported that the device was not used past expiry date.The complainant indicated that the device is implanted and 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 upsylon¿ y-mesh was implanted during a sacrocolpopexy procedure.According to the complainant, during the procedure, the mesh tore down the midline of the sacral tail.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Event Description
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It was reported to boston scientific corporation that an upsylon¿ y-mesh was implanted during a sacrocolpopexy procedure.According to the complainant, during the procedure, the mesh tore down the midline of the sacral tail.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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