MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for FOAM ECG PATCH manufactured by 3m Canada Company.
[144112992]
I had an adverse reaction to the 3m foam ecg patches. My skin was red, oozing under where patches were. Skin is red and dry and very itchy all over chest. Creams do not seem to help. It took only a few hours to get this bad. I have been in and out of hospital a dozen times since 2015 and using these patches. I never developed this reaction until (b)(6) 2019 where skin was just very red and itchy. When admitted on (b)(6) 2019, i informed personnel about recent reaction but patches were put on anyway. The next day they had to remove them because of the terrible reaction i was having. I have pictures to prove my statement. The pediatric patches do not seem to bother me. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086354 |
| MDR Report Key | 8577775 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-04-08 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FOAM ECG PATCH |
| Generic Name | ELECTRODE ELECTROCARDIOGRAPH |
| Product Code | DRX |
| Date Received | 2019-05-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M CANADA COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-02 |