FDA.reportPublic FDA data

MAUDE MDR 3886523

MDR report key
3886523
Report number
1044475-2014-00125
Event key
0
Event type
3
Date of event
2014-04-02
Date received
2014-04-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MARGIE BURTON, RN, REG AFFAIRS
Address
P.O. BOX 12600 RTP NC 27709 US
Phone
919-919-9194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RUSCH MRI COND FIBER OPTIC LARYN KITMRI LARYNGOSCOPE KITTELEFLEXOGH005852300R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-04-140

Event Narratives#

D

Patient 1

THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE WILL NOT LIGHT UP.

N

Patient 1

THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.