Catalog Number PFRT01 |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275); Blood Loss (2597)
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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).(b)(4).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 fda: 05/03/2017.It was reported that the patient underwent a gynecological procedure on (b)(6) 2007 and unknown mesh was implanted.It was reported that following insertion the patient experienced bleeding, incontinence, and urinary frequency.
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Manufacturer Narrative
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It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and prolift was implanted.It was reported that following insertion the patient experienced dyspareunia.It was reported that the patient underwent mesh revision on (b)(6) 2007 by dr.(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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Search Alerts/Recalls
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