MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-24 for ECLIPSE2L ECL2L6X15 N/A manufactured by Balt Usa, Llc.
| Report Number | 3014162263-2020-00003 |
| MDR Report Key | 9747866 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-12-13 |
| Date Added to Maude | 2020-02-24 |
| 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 | MOISES COLIN |
| Manufacturer Street | 29 PARKER |
| Manufacturer City | IRVINE, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECLIPSE2L |
| Generic Name | ECLIPSE2L |
| Product Code | MJN |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-03-12 |
| Model Number | ECL2L6X15 |
| Catalog Number | N/A |
| Lot Number | F191200103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BALT USA, LLC |
| Manufacturer Address | 29 PARKER IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-24 |