Model Number UNKNOWN URETEX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Pain (1994); Injury (2348)
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Event Date 06/20/2006 |
Event Type
Injury
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Manufacturer Narrative
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(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.Product was used for therapeutic treatment.
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Manufacturer Narrative
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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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The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative and postoperative diagnosis was genuine stress urinary incontinence and symptomatic pelvic organ prolapse.The procedure performed was a laparoscopic-assisted vaginal hysterectomy, bilateral salpingo-oophorectomy, cystocele repair, sacrospinous vault fixation, rectocele repair, and tvto procedure.
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Manufacturer Narrative
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Medtronic complaint number: pe:(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, alleged complications post implant include pain, erosion, infection, dyspareunia, vaginal mesh exposure.Mesh revision surgery (b)(6) 2009, underwent resection of vaginal mesh and revision of vaginal cuff for mesh exposure.Mesh revision surgery (b)(6) 2014, underwent complete explant of synthetic graft material from both anterior and posterior approaches.
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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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