Catalog Number 2941001100 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Pressure Sores (2326)
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Event Date 04/30/2021 |
Event Type
Injury
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Event Description
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It was reported that a patient received a pressure injury while on an isoair mattress.It was further reported that it was an unstageable pressure injury.No additional information has been provided regarding the treatment of the injury.
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Manufacturer Narrative
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This supplemental is being filed as the correct model number of the device has been obtained, and the investigation is complete.B5 and h codes updated to reflect investigation results.
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Event Description
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It was reported that a patient received a pressure injury while on an isoair mattress.It was further reported that it was an unstageable coccyx pressure injury.The customer was unable to provide treatment details, and did not make the device available for testing.
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Search Alerts/Recalls
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