RED DOT ECG PATCH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for RED DOT ECG PATCH manufactured by 3m Company, 3m Healthcare.

Event Text Entries

[142271241] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085896
MDR Report Key8518921
Date Received2019-04-15
Date of Report2019-04-11
Date of Event2019-04-08
Date Added to Maude2019-04-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRED DOT ECG PATCH
Generic NameELECTRODE, ELECTROCARDIOGRAPH
Product CodeDRX
Date Received2019-04-15
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
Manufacturer3M COMPANY, 3M HEALTHCARE


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-04-15

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