Catalog Number PVPS |
Device Problem
Hole In Material (1293)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2016 |
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 a hernia repair procedure on (b)(6) 2016 and the mesh was implanted.During the procedure, while working with the mesh, the surgeon ripped a hole in it.Another like device was used to complete the procedure with 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 product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Manufacturer Narrative
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The implant showed a partial separation of one wing on the top at the welding with the load ring.The separated part is fold down and exposed the load ring.No further defect was detected.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.
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Search Alerts/Recalls
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