HOOD, SPP, WHITE, XL

Additional Manufacturer Narrative

THE ORIGINAL SAMPLE WAS REPORTEDLY DISCARDED AND WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SAMPLE'S LOT NUMBER WAS PROVIDED TO THE MANUFACTURER. A SAMPLE FROM THE LOT NUMBER WAS EVALUATED. CYTOXICITY TESTING WAS PERFORMED AND THE REPORTED PRODUCT ISSUE COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A STAFF MEMBER EXPERIENCED A REACTION AFTER PUTTING ON A SURGEON'S HOOD. IT WAS REPORTED THAT AFTER FIVE MINUTES OF USE THE STAFF MEMBER EXPERIENCED REDNESS, BUMPS, AND SWELLING TO THE FACE, NECK, AND FOREHEAD. IT WAS REPORTED THAT THE STAFF MEMBER TOOK BENADRYL AND FOLLOWING AN UNKNOWN PERIOD OF TIME, SELF-ADMINISTERED AN EPI-PEN. IT WAS REPORTED THAT THE STAFF MEMBER CARRIES AN EPI-PEN DUE TO A HISTORY OF ALLERGIES. IT WAS REPORTED THAT THE STAFF MEMBER DID NOT FOLLOW UP WITH A HOSPITAL OR DOCTOR'S OFFICE AFTER THE REPORTED INCIDENT. IT WAS REPORTED THAT AFTER TAKING THE STATED MEDICATIONS THE REPORTED REACTION WAS RESOLVED. IT WAS REPORTED THAT THE ORIGINAL SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT A STAFF MEMBER EXPERIENCED A REACTION AFTER PUTTING ON A SURGEON'S HOOD.