Model Number UNK PELVICOL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Injury (2348); Hematuria (2558)
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Event Date 05/09/2002 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).User facility is listed in initial reporter.(b)(4).
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Event Description
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The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.
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Manufacturer Narrative
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Tracking number: (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Alleged complications post device implant, microscopic hematuria-small amount, stress urinary incontinence, urgency and difficulty with urination.Intervention surgery occurred (b)(6) 2012; cystoscopy and fulguration of small hemangioma.
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Manufacturer Narrative
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Medtronic complaint report: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Per additional information received, the preoperative and postoperative diagnosis was stress urinary incontinence, cystocele.Underwent pubovaginal sling and anterior repair under general plus local infiltration anesthesia.
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Search Alerts/Recalls
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