Catalog Number SEE H10 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Incontinence (1928)
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Event Date 08/20/2014 |
Event Type
Injury
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Event Description
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It was reported that the patient is scheduled to have an action device revision surgery on (b)(6) 2014 due to "persistent fecal incontinence." no patient complications were reported in relation with this event.
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Manufacturer Narrative
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Cuff catalog #: 72401978; exp.Date: 04/22/2014; serial#:(b)(4); mfg date: 05/2009; implanted (b)(6) 2009.Pump catalog #: 72402287; exp.Date: 07/08/2014; serial #: (b)(4); mfg date: 07/2009; implanted (b)(6) 2009.Balloon catalog #: 72402106; exp.Date: 04/13/2014; serial # (b)(4); mfg date: 04/2009; implanted (b)(6) 2009; the device remains implanted.
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Event Description
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It was reported that the patient had his acticon device replacement surgery on (b)(6) 2014.No patient complications were reported in relation with this event.
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Search Alerts/Recalls
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