MAUDE MDR 8518921

MDR report key
8518921
Report number
MW5085896
Event key
0
Event type
3
Date of event
2019-04-08
Date received
2019-04-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RED DOT ECG PATCHELECTRODE, ELECTROCARDIOGRAPH3M COMPANY, 3M HEALTHCAREDRXI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-1501. H

Event Narratives#

D

Patient 1

ON (B)(6) 2018 (B)(6) ER PLACED 3M RD DOT ECG PATCHES ON ME FOR MONITORING. I TOLD THEM THAT I HAD DEVELOPED A REACTION TO THE PADS IN THE HOSP 3 WEEKS EARLIER, BUT CONSIDERED IT MIGHT BE A RANDOM CASE BECAUSE OVER THE COURSE OF THE LAST 4 YEARS AND NUMEROUS HOSP STAYS NO REACTION SUCH AS THIS ONE WAS EXPERIENCED. I WAS ADMITTED FOR THE PURPOSE OF ABLATION / PACEMAKER PROCEDURE. TWO DAYS LATER, THE DR HAD TO CANCEL MY PROCEDURE RIGHT BEFORE STARTING, BECAUSE OF THE SEVERE ALLERGIC REACTION, WHEREVER THE PADS WERE PLACED, MY SKIN WAS DEEP RED, RAISED, ITCHY AND SOME WERE OOZING. IN BETWEEN THOSE AREAS, THE SKIN WAS RED AND ITCHY. DR WOULD NOT RISK INFECTION, SO PROCEDURE WAS CANCELED. I AM NOW IN HOSP TREATING SKIN WITH STEROID SHOTS, OINTMENTS SO THIS CAN CLEAR AND WE CAN GO ON THE PROCEDURE. I HAVE PICTURES OF THE REACTION AND THE PATCHES THAT CAUSED IT. FOR SOME REASON I CAN WEAR THE PEDIATRIC PATCHES WITHOUT ANY ADVERSE EFFECTS. THANK YOU, (B)(6). FDA SAFETY REPORT ID# (B)(4).