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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
Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer reference number: (b)(4).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 stress urinary incontinence, abnormal bleeding, and severe dysmenorrhea.The procedure performed was a pubovaginal sling, d<(>&<)>c hysteroscopy, and endometrial ablation.The patient returned for an office visit on (b)(6) 2006 for a normal postoperative visit.The patient returned for an office visit on (b)(6) 2006 for a postoperative visit.The patient had noticed some sharp pains at the left incision site and suprapubic area that was very knife like stabbing pains that occurred after she has been moving around.The patient can feel the suture somewhat beneath the incision itself.The patient returned for an office visit in (b)(6) of 2008.There was an off-white discharge with a slight odor coming from the cervix.
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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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Search Alerts/Recalls
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