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Model Number UNK PELVICOL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Urinary Tract Infection (2120); 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.Lot number not provided.Udi not provided.Re-processing information not provided.Device manufacture date: since the lot number was not provided, this information cannot be determined.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 symptomatic pelvic relaxation.The procedure performed was a bilateral paravaginal repair with mesh grafting, posterior repair with mesh grafting and vault suspension.An additional procedure was performed at the same time.The preoperative and postoperative diagnosis was symptomatic cholecystectomy.The procedure performed was a laparoscopic cholecystectomy with cholangiogram.The patient returned for an office visit on (b)(6) 2005 for postop visit.The patient returned for a postop visit on (b)(6) 2005.The patient underwent an additional procedure on (b)(6) 2007.The preoperative and postoperative diagnosis was enterocele, rectocele, and apical prolapse.The procedure performed was an enterocele repair, bilateral sacrospinous fixation, and posterior repair with prolene mesh.The patient returned for an office visit on (b)(6) 2007 for post-op visit.Improved bladder spasms was noted.The patient returned for an office visit on (b)(6) 2007 because the patient continued to have bladder problems.The patient returned for an office visit on (b)(6) 2007 to insert pessary.The patient returned for an office visit on (b)(6) 2007 for failed pessary.The patient underwent an additional procedure on (b)(6) 2007.The preoperative and postoperative diagnosis was recurrent cystocele and small amount of apical prolapse.The procedure performed was a repair of recurrent cystocele.
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Manufacturer Narrative
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Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.
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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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