MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-27 for LINA POWER MORCELLATOR MOR-1515-6 manufactured by Lina Medical Aps.
| Report Number | 3007699067-2019-00003 |
| MDR Report Key | 8738374 |
| Date Received | 2019-06-27 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-06-07 |
| Date Mfgr Received | 2019-06-11 |
| Device Manufacturer Date | 2018-05-22 |
| Date Added to Maude | 2019-06-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MONIKA LEWANDOWSKA |
| Manufacturer Street | FORMENVANGEN 5 DENMARK |
| Manufacturer City | GLOSTRUP, DK2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK2600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LINA POWER MORCELLATOR |
| Generic Name | LINA MORCELLATOR |
| Product Code | HET |
| Date Received | 2019-06-27 |
| Model Number | MOR-1515-6 |
| Catalog Number | MOR-1515-6 |
| Lot Number | 1821015 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | FORMERVANGEN 5 GLOSTRUP, DK2600 DA DK2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-27 |