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Catalog Number 8005P10 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Urinary Tract Infection (2120)
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Event Date 10/12/2012 |
Event Type
Other
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Event Description
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A pt (b)(6) was enrolled in (b)(6) study for stress urinary incontinence.On (b)(6) 2011, the pt was injected with 3.0 ml coaptite, lot 1014840.On (b)(6) 2012, the pt developed urinary tract infection reported by a pt.On (b)(6) 2012, the pt was treated with antibiotic ciprofloxacin 500mg every 12 hrs x 7 days.The adverse event resolved on (b)(6) 2012.Per physician, the event was of mild severity and probably not related to coaptite.On (b)(6) 2013, the pt developed urinary tract infection reported by a pt.On (b)(6) 2013, the pt was treated with keflex 250mg qid x 20.The adverse event resolved on (b)(6) 2013.Per physician, the event was of mild severity and probably not related to coaptite.
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Manufacturer Narrative
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On (b)(6) 2013, the pt developed urinary tract infection reported by a pt.On (b)(6) 2013 the pt was treated with antibiotic cipro 500mg bid x 7 days.The adverse event resolved on (b)(6) 2013.Per physician, the event was of mild severity and probably not related to coaptite.On (b)(6) 2013, the pt developed urinary tract infection identified by urinalysis.On (b)(6) 2013, the pt was treated with antibiotic cefdinir, omnicef 300mg 2 x 7 days and then nightly.Keflex for 6 weeks after cefdinir/omnicef.The adverse event resolved in (b)(6) 2013.Per physician, the event was of mild severity and probably not related to coaptite.At the time of this report, the urinary tract infections have resolved.The device history records for the reported lot were reviewed, all required testing specs were met prior to release, there were no abnormalities noted.
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Search Alerts/Recalls
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