Catalog Number 0400205000 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Irritation (1941)
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Event Date 09/23/2014 |
Event Type
Injury
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Event Description
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It was reported that during a surgical procedure conducted at the user facility, the user had a dermal allergic reaction localized to the area where the device touched the user¿s head.The procedure was completed successfully without a delay.The user sought medical advice for the allergic reaction; however, the user facility was not able to provide any further information regarding any treatment and/or medication administered as a result of this event.
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Event Description
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It was reported that during a surgical procedure conducted at the user facility the user had a dermal allergic reaction localized to the area where the device touched the user¿s head.The procedure was completed successfully without a delay.The user sought medical advice for the allergic reaction; however, the user facility was not able to provide any further information regarding any treatment and/or medication administered as a result of this event.
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Manufacturer Narrative
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The device is available for evaluation but has not yet been received.Additional information will be submitted once the device is received and the quality investigation is completed.The device has not been returned for analysis at this time.
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Manufacturer Narrative
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The reported event was not duplicated and no additional failures were confirmed.The device was tested for contamination and it was confirmed that no trace residues were present that could cause or contribute to the reported event.
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Search Alerts/Recalls
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