MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-05-14 for 3M? RED DOT? FOAM MONITORING ELECTRODES N/A 2560 manufactured by 3m Health Care.
[145035179]
Lot number: product lot number was not provided. Initial reporter also sent report to fda: mw5085896 and mw5086354 were received from the fda. Additional information was received on 5/14/19. The consumer reported the reaction improved and she was able to have her pacemaker procedure seven days following the reaction. The reaction on her chest had reportedly improved, some itching and dry skin remained on her chest. The sites on her abdomen were still visible (red outline) where the electrodes had been applied.
Patient Sequence No: 1, Text Type: N, H10
[145035180]
The fda notified 3m of an adverse event via a medwatch report. A consumer reported the following information to the fda: in 2018, er placed 3m red 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 with 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00077 |
| MDR Report Key | 8609500 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-05-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M CANADA COMPANY |
| Manufacturer Street | 400 ROUTE 100 |
| Manufacturer City | MORDEN, R6M 1Z9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | R6M 1Z9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? RED DOT? FOAM MONITORING ELECTRODES |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-05-14 |
| Model Number | N/A |
| Catalog Number | 2560 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-14 |