MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-18 for FL23P manufactured by Umano Medical Inc.
| Report Number | 3009591865-2019-00014 |
| MDR Report Key | 8804669 |
| Date Received | 2019-07-18 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-06-20 |
| Device Manufacturer Date | 2013-07-22 |
| Date Added to Maude | 2019-07-18 |
| 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 MAUDE THIBAULT |
| Manufacturer Street | 230 BOULEVARD NILUS-LECLERC |
| Manufacturer City | L'ISLET, QUEBEC G0R 2C0 |
| Manufacturer Country | CA |
| Manufacturer Postal | G0R 2C0 |
| Manufacturer G1 | UMANO MEDICAL INC |
| Manufacturer Street | 230 BOULEVARD NILUS-LECLERC |
| Manufacturer City | L'ISLET, QUEBEC G0R 2C0 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | G0R 2C0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FL23P |
| Generic Name | MANUAL BED |
| Product Code | FNJ |
| Date Received | 2019-07-18 |
| Model Number | FL23P |
| Catalog Number | FL23P |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UMANO MEDICAL INC |
| Manufacturer Address | 230 BOULEVARD NILUS-LECLERC L'ISLET, QUEBEC G0R 2C0 CA G0R 2C0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-18 |