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Catalog Number PHY1520R |
Device Problems
Tears, rips, holes in device, device material (1628); Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Hernia (2240); Surgical procedure (2357)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent ventral hernia repair procedure on an unknown date and mesh was implanted.Approximately two years after the procedure, the patient experienced recurrence.The patient underwent a laparoscopic surgical procedure and a hole was found in the middle of the mesh.The hernia was repaired with mesh.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.(b)(4).
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Search Alerts/Recalls
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