Catalog Number 90432 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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This report is filed, june 6, 2016.The implanted device remains.
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Event Description
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It was reported that the patient may have developed an infection at the implant site.The implanted device remains.
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Manufacturer Narrative
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Per the clinic, the patient experienced an infection of the mastoid bone and subsequently underwent surgery to remove infected bone (date not reported).This report is submitted february 20, 2017.
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Manufacturer Narrative
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Correction: the previous follow up mdr submitted on february 20, 2017, was filed inadvertently.The infection was not device related.This report is filed on february 24, 2017.(b)(4).
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Search Alerts/Recalls
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