MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-05 for LUCEA 40 MOBILE LUCEA40 manufactured by Maquet S.a.s..
Report Number | 8859506 |
MDR Report Key | 8859506 |
Date Received | 2019-08-05 |
Date of Report | 2019-07-25 |
Date of Event | 2019-06-21 |
Report Date | 2019-07-25 |
Date Reported to FDA | 2019-07-25 |
Date Reported to Mfgr | 2019-08-05 |
Date Added to Maude | 2019-08-05 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | LUCEA 40 MOBILE |
Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
Product Code | FSS |
Date Received | 2019-08-05 |
Model Number | LUCEA40 |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MAQUET S.A.S. |
Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-08-05 |