MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-10-29 for ELECTRODE ECL 530 MEDITRACE FM 31013926 manufactured by Covidien.
| Report Number | 9681860-2019-00507 |
| MDR Report Key | 9250757 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-29 |
| Date of Event | 2019-09-20 |
| Date Mfgr Received | 2019-09-30 |
| Date Added to Maude | 2019-10-29 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 215 HEBERT ST |
| Manufacturer City | GANANOQUE K7G 2Y7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K7G 2Y7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRODE ECL 530 MEDITRACE FM |
| Generic Name | ELECTRODE, ELECTROCARDIOGRAPH |
| Product Code | DRX |
| Date Received | 2019-10-29 |
| Model Number | 31013926 |
| Catalog Number | 31013926 |
| Lot Number | 907449X |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 215 HEBERT ST GANANOQUE K7G 2Y7 CA K7G 2Y7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-29 |