Catalog Number PFRT01 |
Device Problems
Migration or Expulsion of Device (1395); Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Erosion (1750); Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified complications.No additional information has been provided.
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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.
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Manufacturer Narrative
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Date sent to the fda: 05/04/2017.(b)(4).It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and mesh was placed into the patient¿s body.It was reported that the patient underwent mesh revision due to erosion on (b)(6) 2013 by (b)(6).In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
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Manufacturer Narrative
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It was reported that the patient underwent a gynecological surgical procedure and a mesh was implanted concurrently with cystoscopy.
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Search Alerts/Recalls
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