MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for 3M RED DOT ECG ELECTRODE 2670-5 manufactured by 3m Health Care.
[133774063]
Snap separates from the ecg electrode. This has occurred numerous times. This has significant implications to patient care. This is event #1 of 2 with the same lot number on the same emergency incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083210 |
| MDR Report Key | 8260641 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-11-10 |
| Date Added to Maude | 2019-01-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3M RED DOT ECG ELECTRODE |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-01-17 |
| Model Number | 2670-5 |
| Catalog Number | 2670-5 |
| Lot Number | 202006FH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |