FIRST AID KIT WITHOUT DRUG

Additional Manufacturer Narrative

IT WAS REPORTED THAT A (B)(6) CHILD EXPERIENCED A SCRAPE ON HIS SHIN WHICH HIS MOTHER REPORTEDLY COVERED WITH OVER THE COUNTER ANTIBIOTIC CREAM AND A BANDAGE. THE CHILD'S MOTHER STATED THAT 30 MINUTES AFTER THE APPLICATION OF THE BANDAGE HER SON STARTED TO EXPERIENCE BLISTERS IN THE AREA OF THE BANDAGE ADHESIVE AND WAS GASPING FOR BREATH LIKE HE WAS EXPERIENCING AN ANAPHYLACTIC REACTION. THE CHILD'S MOTHER STATED THAT SHE WENT TO THE PHARMACY, GOT AN EPI-PEN AND INJECTED HER SON WITH THE EPI-PEN WHICH RESOLVED THE SYMPTOMS OF GASPING FOR BREATH. THE CHILD'S MOTHER STATED THAT SHE COVERED THE BLISTERS ON THE SHIN WITH A GAUZE PAD AND TAPE WITHOUT FURTHER INCIDENT. THE CHILD HAS A KNOWN ALLERGY TO LATEX BUT NO OTHER KNOWN ALLERGIES WERE REPORTED. THE CHILD'S MOTHER CALLED THE CHILD'S PEDIATRICIAN THE MORNING AFTER THE INCIDENT OCCURRED TO REPORT THE CHILD'S SYMPTOMS AND THE USE OF AN EPI-PEN AND THE PEDIATRICIAN INSTRUCTED THE MOTHER TO MONITOR THE CHILD AND NO FOLLOW UP WAS NECESSARY AT THIS TIME. THE ACTUAL SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION DUE TO THE ACTUAL SAMPLE INVOLVED IN THE INCIDENT BEING THROWN AWAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT, NEED FOR INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE END USER DEVELOPED AN ALLERGIC REACTION AFTER WEARING THE BANDAGE AND WAS TREATED WITH AN EPI-PEN INJECTION.