Catalog Number 5526 |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 04/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.
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Event Description
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Customer complaint alleges the device handle reaches high temperatures.Alleged issue reported as detected during use.No report of patient or user harm or consequence.
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Manufacturer Narrative
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(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.
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Event Description
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Customer complaint alleges the device handle reaches high temperatures.Alleged issue reported as detected during use.No report of patient or user harm or consequence.
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Search Alerts/Recalls
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