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 |