Catalog Number PFRT01 |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275)
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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).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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It was reported that the patient underwent gynecological procedure on (b)(6) 2009 and prolift was implanted.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 05/24/2017.It was reported that the patient underwent a gynecological surgical procedure and mesh was implanted concurrently with cystoscopy and perineoplasty.It was reported that following insertion the patient experienced urinary urgency, urinary frequency, urge incontinence and stress incontinence.
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Search Alerts/Recalls
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