Model Number PROPHYFLEX 3 2018 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Code Available (3191)
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Event Date 04/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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It is the nature of an air-flow-system that at the end of the cannula an airflow mixed with water and powder gets exhausted.This is the intended function of the product.To avoid the occurrence of an emphysema the 'instruction of use' contains already a warning that it should be avoided to blow directly in damaged tissue and/or open wounds.From current point of view a wrong use of the product lead to the incident.Product was not returned for analysis, yet.In case it gets returned and the analysis brings new findings a follow up report will be sent.
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Event Description
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Described is that during the treatment with the product (an air-flow-system) the user suddenly noticed that the right eye was swollen.Patient was not able to open the eye anymore.Dental staff directly cooled the area and called an emergency physician.It was clarified that it was not an anaphylactic reaction but an emphysema.To be on the safe side the patient has been brought to hospital for 3 days to monitor her.
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Search Alerts/Recalls
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