N
Patient 1
THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. DEVICE NOT RETURNED TO MANUFACTURING SITE.
MAUDE MDR 9422954
- MDR report key
- 9422954
- Report number
- 9710055-2019-00346
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-06
- Date received
- 2019-12-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. PASCAL JAY
- Address
- PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LUCEA 10 | DEVICE, MEDICAL EXAMINATION, AC POWERED | MAQUET SAS | KZF | ARD568602971 | ARD568602971 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-12-06 | 0 |
Event Narratives#
D
Patient 1
ON (B)(6) 2019 GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 10 LIGHT. AS IT WAS STATED, THE CONNECTION BETWEEN MAIN TUBE AND SUSPENSION ARM WAS CRACKED. THERE WAS NO INJURY REPORTED. TAKING INTO CONSIDERATION THE WORST CASE SCENARIO WHICH IS THE DETACHMENT OF EXAMINATION LIGHT, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL.