Model Number CI24RE (L24) |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Bacterial Infection (1735)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on july 28, 2016, by cochlear limited on behalf of (b)(4).Registration number 3009092818.Exemption number (b)(4).Implanted device remains.
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Event Description
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Per the clinic, the patient developed an infection at the implant site and was subsequently hospitalized (date not reported) and treated with iv antibiotics twice daily, for a duration of 6 weeks.
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Manufacturer Narrative
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Correction - the address provided for the initial reporter was incorrect as the report source was the patient; not their clinic.
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Search Alerts/Recalls
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