FDA.reportPublic FDA data

MAUDE MDR 8263911

MDR report key
8263911
Report number
8020045-2019-00002
Event key
0
Event type
3
Date received
2019-01-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. BURRHUS LANG
Address
ARCHENWEG 56 INNSBRUCK, TIROL 6020 AU
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SKINTACTECG ELECTRODELEONHARD LANG GMBHDRXF-55R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-2101. O

Event Narratives#

N

Patient 1

AS NEITHER A LOT NUMBER NOR SAMPLES HAVE BEEN MADE AVAILABLE TO US, NO ANALYSES COULD BE PERFORMED SO FAR. THE PHYSICIAN HAS ASKED FOR INGREDIENTS OF THE ELECTRODE TO DETERMINE IF AN ALLERGY HAS CAUSED THE REACTION. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN INJURY CAN BE DRAWN SO FAR. WE HAVE REQUESTED FURTHER INFORMATION (SKIN PREPARATION, TREATMENT OF RASH) AND WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT.

D

Patient 1

ON (B)(4) 2018, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL F55) AND AN UNKNOWN HEART MONITORING RECORDER HAD BEEN USED. THE INITIAL REPORTER STATED "I SAW A PATIENT WHO DEVELOPED A SKIN RASH AFTER HOLTER MONITORING FOR 24 HOURS WITH THE SKINTACT ECG ELECTRODES (F-55, AQUA WET TYPE). THE SKIN RASH WAS EXACTLY ON THE SITES OF ECG ELECTRODE FIXATION THE DAY BEFORE. WE WOULD LIKE TO KNOW THE INGREDIENTS OF THE GEL/FOAM IN THE CENTRAL PART OF THE SKINTACT ECG ELECTRODES. IS THIS SUBSTANCE PERFUMED? DOES IT CONTAIN ACRYLATES OR OTHER PRODUCTS?" NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURY HAD TO BEEN TREATED.