Model Number 5100015252 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 09/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.
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Event Description
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This report summarizes 1 malfunction event in which the device reportedly overheated.1 event had the patient receive a first-degree burn.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by a damaged collar.
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Event Description
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This report summarizes 1 malfunction event in which the device reportedly overheated.1 event had the patient receive a first-degree burn.
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Search Alerts/Recalls
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