MAUDE MDR 2660730

MDR report key
2660730
Report number
1064095-2012-00002
Event key
0
Event type
3
Date of event
2012-05-31
Date received
2012-07-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1820 2ND AVENUE NORTH LAKE WORTH FL 33461 US
Phone
561-561-5615
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COLLODIAN IICOLLODIONMAVIDON MEDICAL PRODUCTSIAWMDCOLIIUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-07-1201. H

Event Narratives#

D

Patient 1

A PATIENT HAD A 24 HOUR EEG LEAD PLACED USING COLLODION AND WAS SENT HOME. THE PATIENT BEGAN TO FEEL VERY HOT, SWEATING, ITCHING AND RED COLOR SPOTS ON HER HEAD. SHE WAS SENT TO THE ED (EMERGENCY DEPARTMENT). IN THE ED THE PATIENT WAS NOTED AS HAVING AN ALLERGIC REACTION WITH SHORTNESS OF BREATH, THROAT SWELLING, HIVES, DIZZINESS, TACHYCARDIA AND EXPIRATORY WHEEZES. OXYGEN WAS APPLIED; ALBUTEROL VIA NEBULIZER AND EPINEPHRINE SUBCUTANEOUS WAS ADMINISTERED. THE PATIENT'S HEAD WAS SHAVED TO REMOVE ALL TRACES OF GLUE BELIEVED TO BE CAUSING THE REACTION. PATIENT WAS STABILIZED AND DISCHARGED HOME.

N

Patient 1

DURING THE EEG PROCEDURE AS DESCRIBED IN THIS REPORT THERE ARE A NUMBER OF ITEMS THAT WERE USED DURING THE PROCEDURE: NUPREP BY WEAVER AND COMPANY; TEN20 CONDUCTIVE PAST BY WEAVER AND COMPANY; ELECTRODES BY NIHON KOHDEN; COLLODION II BY MAVIDON. THE SUSPECTED MEDICAL DEVICE IN THE REPORT WAS COLLODION II. THIS IS A FAST DRYING ADHESIVE MADE WITH ETHYL ACETATE AND ISOPROPANOL AS THE SOLVENTS AND CELLULOSE NITRATE (NITROCELLULOSE) IS THE RESIN. ONCE THE SOLVENTS EVAPORATE THE ONLY REMAINING INGREDIENT IS NITROCELLULOSE. NITROCELLULOSE IS COMMONLY USED IN OTHER SKIN CONTACT PRODUCTS SUCH AS COMPOUND W AND NEW SKIN LIQUID BANDAGE. WE HAVE NEVER RECEIVED ANY COMPLAINTS OF THIS TYPE IN THE PAST FOR COLLODION II. NUPREP SKIN PREP IS USED TO CLEAN THE ELECTRODE SITE AND WILL LEAVE A RESIDUE OF THE GEL UNTIL CLEANED AFTER THE PROCEDURE. THE TEN20 CONDUCTIVE PAST REMAINS ON THE PATIENT THROUGHOUT THE PROCEDURE. WE NOTICED IN SECTION 7 THAT THE PATIENT HAS A HISTORY OF MANY ALLERGIES. THOUGH WE CANNOT ABSOLUTELY SAY COLLODION II DID NOT CAUSE THIS REACTION, WE MUST ALSO LOOK AT THE OTHER PRODUCTS USED SINCE THEY REMAIN ON THE SKIN FOR LONGER PERIODS OF TIME WHICH MAY OR MAY NOT CAUSE AN ALLERGIC REACTION.