FDA.reportPublic FDA data

MAUDE MDR 5204466

MDR report key
5204466
Report number
9680866-2015-31375
Event key
0
Event type
3
Date of event
2014-10-22
Date received
2015-11-05
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
JEANETTE JOHNSON
Address
211 AMERICAN AVE GREENSBORO NC 27409 US
Phone
336-336-3362
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADULT OXYGEN MASK WITH TUBING,02 DILUTER JETS (6),OXYGEN TUBE, NEBULIZER HOODMASK, OXYGEN, LOW CONCENTRATION, VENTURIUNOMEDICAL SA DE CVBYFI002610Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-050

Event Narratives#

N

Patient 1

CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

D

Patient 1

CUSTOMER REPORTED THAT THE WHISTLE SOUND WAS HEARD FROM THE CONNECTION BETWEEN THE OXYGEN AND THE FLOWMETER, SO THE DEVICE WAS CHANGED TO THE NEW ONE.