MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-19 for 3M? RED DOT? MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL N/A 2570 manufactured by 3m Health Care.
[182295400]
Patient information: no information was provided. Date of event: exact date of event was not provided. Date received by manufacturer was used as the d. O. E. The sample was not returned for evaluation. 3m will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[182295401]
A hospital employee reported that 3m? Red dot? Monitoring electrodes with foam tape and sticky gel, model 2570, are getting stuck in the lead wires, where the electrode buttons came off the electrode pad and stayed lodged in the lead snap. A non-3m brand of ecg lead wires was used by the facility. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00007 |
| MDR Report Key | 9727401 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-19 |
| 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 | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7379117 |
| 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? MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2020-02-19 |
| Model Number | N/A |
| Catalog Number | 2570 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |