MAUDE MDR 7786073

MDR report key
7786073
Report number
1417592-2018-00076
Event key
0
Event type
3
Date of event
2018-07-25
Date received
2018-08-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KAREN TRUTSCH
Address
THREE LAKES DR NORTHFIELD IL 60093 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FIRST AID KIT WITHOUT DRUGMEDLINE INDUSTRIES INC.OHOCURFAK300RB75716090003R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-1501. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

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