ETHICON SARL GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Catalog Number PROA1 |
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); Incontinence (1928); Urinary Retention (2119); 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).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 that the patient underwent gynecological surgical procedure on (b)(6) 2010 and prosima was implanted.It was reported that following insertion the patient experienced erosion, urinary frequency, nocturia, urgency, hesitancy, and urinary retention.It was reported that patient underwent mesh excision on (b)(6) 2011 by dr.(b)(6) due to exposed mesh at p & s surgical hospital.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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(b)(4).It was reported that following insertion the patient experienced overactive bladder, incontinence, prolapsed vagina, and rectocele.
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Search Alerts/Recalls
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