MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2019-10-11 for 3M? RED DOT? SOFT CLOTH MONITORING ELECTRODES N/A 2660-5 manufactured by 3m Health Care.
| Report Number | 2110898-2019-00116 |
| MDR Report Key | 9182944 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2019-10-11 |
| Date of Report | 2019-10-11 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2019-09-16 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2019-10-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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? SOFT CLOTH MONITORING ELECTRODES |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-10-11 |
| Model Number | N/A |
| Catalog Number | 2660-5 |
| Lot Number | 2020 -04 FC |
| Operator | LAY USER/PATIENT |
| 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. Life Threatening; 2. Required No Informationntervention | 2019-10-11 |