MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-01 for LINA BIPOLAR LOOP BL-200 manufactured by Lina Medical Aps.
| Report Number | 3007699067-2019-00004 |
| MDR Report Key | 9138244 |
| Date Received | 2019-10-01 |
| Date of Report | 2019-10-01 |
| Date Mfgr Received | 2019-09-10 |
| Device Manufacturer Date | 2018-12-03 |
| Date Added to Maude | 2019-10-01 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MONIKA LEWANDOWSKA |
| Manufacturer Street | FORMENVANGEN 5 |
| Manufacturer City | GLOSTRUP, 2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2600 |
| Manufacturer G1 | MONIKA LEWANDOWSKA |
| Manufacturer Street | ROLNA 8A |
| Manufacturer City | SADY, 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LINA BIPOLAR LOOP |
| Generic Name | LINA BIPOLAR LOOP |
| Product Code | HIN |
| Date Received | 2019-10-01 |
| Model Number | BL-200 |
| Catalog Number | BL-200 |
| Lot Number | 1849006 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | FORMENWANGEN 5 GLOSTRUP, 2600 DA 2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-01 |