Model Number 93550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional information has been requested regarding product brand and model: this information has been made available as of the date of this report.Should further information be provided, a supplementary report shall be submitted.This report is submitted on january 15, 2020.
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Event Description
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Per the clinic, the patient experienced poor magnet retention.The patient had a thinning of the skin flap on an unknown date but still experiences poor magnet retention.Clinical management is ongoing.
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Event Description
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Per the clinic, it was reported that for audiological purposes, the internal magnet was removed in order to convert the patient to a percutaneous baha implant system.An abutment was placed on the implant fixture, which remains insitu.No other event or complications which may have contributed to the decision to convert the patient were reported.
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Manufacturer Narrative
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This report is submitted on 26 february 2020.
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Search Alerts/Recalls
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