Catalog Number PFRF01 |
Device Problem
Material Erosion (1214)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Discomfort (2330); Surgical procedure (2357)
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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 a mesh was implanted.It was reported that the patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was 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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(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and a mesh was implanted.It was reported that patient underwent placement of a permanent implantable programmable generator sns (interstim) stage 1 due to urinary retention on (b)(6) 2009 and sns stage 2 on (b)(6) 2009.No additional information was provided.
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Manufacturer Narrative
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It was reported that patient underwent and laparoscopic lysis of adhesions and a intraoperative transgastric remnant gastroscopy on (b)(6) 2013.
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Search Alerts/Recalls
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