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Model Number UNKPARUGYTEX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abnormal Vaginal Discharge (2123); Injury (2348); Prolapse (2475)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Incident date was not provided.Date of manufacture: since the lot number was not provided, this information cannot be determined.
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Event Description
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The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.The preoperative diagnosis was grade iii cystocele and grade ii rectocele.The postoperative diagnosis was grade iii cystocele, grade ii rectocele, and grade iii enterocele.The procedure performed was a mesh cystocele and rectocele repair with mesh implantation both anteriorly and posteriorly.At the same time, an additional procedure was performed.The preoperative and postoperative diagnosis was recurrent cystocele, recurrent rectocele, and need for urethral support in conjunction with anterior repair and posterior repair.The procedure performed was a tension-free vaginal tape sling and cystoscopy.The patient underwent an additional procedure on (b)(6) 2006.The preoperative and postoperative diagnosis was grade ii enterocele.The procedure performed was an abdominal sacral colpopexy.
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Manufacturer Narrative
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Tracking #pe:(b)(4).
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Event Description
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Alleged complications post device implant: 2010: vaginal discharge, mesh excision and granulation cauterization.Mesh revision surgery: 2012 cystocele repair and enterocele repair, and vaginal cuff suspension, excision of exposed mesh, posterior colporrhaphy, perineorrhaphy and cystoscopy.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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