Catalog Number PVPS |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.
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Event Description
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It was reported that the patient underwent an open ventral hernia procedure and mesh was implanted.The patch was opened and placed into the hernia.As the surgeon pulled up on the tabs, one tab pulled completely off the mesh.Another device was opened and used to complete the procedure.There were no patient consequences reported.
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Manufacturer Narrative
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Received one actual sample.Based on the visual inspection both straps and the non-absorbable part of the implant are still intact.The observed partial separation of the wings at the welding with the load ring may occur during handling and does not have any effect on the product properties and functionality.
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Search Alerts/Recalls
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