Catalog Number 8001000001 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Tissue Damage (2104)
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Event Date 05/30/2017 |
Event Type
malfunction
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Event Description
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It was alleged by the customer that the patient formed blisters during use of the device.
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Manufacturer Narrative
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This device was incorrectly reported, it was identified during the complaint investigation that this device did not cause or contribute to the alleged event.
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Event Description
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It was alleged by the customer that the patient formed blisters during use of the device.
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Manufacturer Narrative
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Supplemental submitted to include udi.
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Event Description
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It was alleged by the customer that the patient formed blisters during use of the device.
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Search Alerts/Recalls
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