MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-26 for 3M? RED DOT? RESTING EKG ELECTRODES N/A 2360 manufactured by 3m Health Care.
[143385751]
A consumer reported approximately eight 2360 3m? Red dot? Ekg resting electrodes were applied to her legs, arms, collar bone and under her breast for less than 5 minutes during an ekg test. Later the same day, the consumer reportedly experienced red raised bumps, itching and welts where each electrode had been applied. The following day, itching, hives, redness and a rash spread outward from each electrode site. The consumer was seen by her primary physician and was treated with a steroid injection. The consumer reported the reaction was improving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00068 |
| MDR Report Key | 8555879 |
| Report Source | CONSUMER |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-04-26 |
| 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 HEALTHCARE/3M VALLEY |
| Manufacturer Street | 600 EAST MEIGS ST. |
| Manufacturer City | VALLEY NE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? RED DOT? RESTING EKG ELECTRODES |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-04-26 |
| Model Number | N/A |
| Catalog Number | 2360 |
| 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. Required No Informationntervention | 2019-04-26 |