FDA.reportPublic FDA data

MAUDE MDR 9883828

MDR report key
9883828
Report number
9710055-2020-00049
Event key
0
Event type
3
Date received
2020-03-26
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 table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LUCEA 40DEVICE, MEDICAL EXAMINATION, AC POWEREDMAQUET SASKZFARD568601997N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-260

Event Narratives#

N

Patient 1

ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

D

Patient 1

ON (B)(6) 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE LIGHT ? LUCEA. AS IT WAS STATED THE PLASTIC CASING OF THE LUCEA WAS BROKEN AND DUE TO THIS WAS REMOVED FROM THE ROOM. CUSTOMER DID NOT PROVIDE ANY INFORMATION ABOUT ANY PARTS FALLING DOWN HOWEVER ON THE PROVIDED PHOTOGRAPHIC EVIDENCE LACK OF SOME PARTICLES WAS NOTICED, THEREFORE WE COULD SUSPECTED THAT SOME OF THEM POTENTIALLY FELL DOWN. TAKING UNDER CONSIDERATION COLLECTED UP TO DATE INFORMATION WE DECIDED TO REPORT THIS CASE BASED ON POTENTIAL AS ANY PARTS FALLING FROM THE DEVICE MIGHT CAUSE CONTAMINATION. MANUFACTURER'S REFERENCE NUMBER: (B)(4).