Catalog Number 004411100 |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problems
Burn(s) (1757); No Patient Involvement (2645)
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Event Date 12/21/2017 |
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 in progress.
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Event Description
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Customer complaint alleges "handle malfunction - bulk (bulb) staying on and over heating handle even when blade is not engaged".There was no report of patient involvement.Reporter states user was burned.There was no report of necessary medical intervention.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Customer complaint alleges "handle malfunction - bulk (bulb) staying on and over heating handle even when blade is not engaged".There was no report of patient involvement.Reporter states user was burned.There was no report of necessary medical intervention.
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Search Alerts/Recalls
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