Catalog Number PVPS |
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 Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent to the fda: 01/24/2017.Attempts have been made to retrieve the device.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 umbilical hernia repair procedure on unknown date and the mesh was implanted.During the procedure, when the doctor started to suture the implanted mesh, the tab pulled off of the mesh product.The mesh was removed and another like device was used to complete the procedure.There were no patient consequences reported.No further information is available.
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Manufacturer Narrative
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In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The cause of the strap breakage could not be clarified.The 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.It should be noted that before pvp placement enough space should be prepared to ensure proper unfolding of the device.Once the mesh patch has been inserted into the defect, manipulate the suture loops to facilitate proper positioning of the patch.
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Search Alerts/Recalls
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