FDA.reportPublic FDA data

MAUDE MDR 8270804

MDR report key
8270804
Report number
3004365956-2019-00019
Event key
0
Event type
3
Date of event
2019-01-11
Date received
2019-01-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KATHARINE TARPLEY
Address
3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
Phone
919-919-9194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HUDSON MASK,MEDIUM CONC,ADULTMASK, OXYGENTELEFLEX MEDICALBYG104074F1801261Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-230

Event Narratives#

N

Patient 1

(B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION AT THE TIME OF THIS REPORT. THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. TO PERFORM A PROPER AND THOROUGH INVESTIGATION, TO CONFIRM THE COMPLAINT AND DETERMINE A ROOT CAUSE, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED. IF THE SAMPLE BECOMES AVAILABLE THIS REPORT WILL BE UPDATED WITH THE EVALUATION RESULTS.

D

Patient 1

CUSTOMER COMPLAINT ALLEGES "THE OXYGEN TUBE AND THE ADAPTOR WAS EASILY DISCONNECTED BEFORE USE. THEREFORE, A NEW PACKAGE WAS USED INSTEAD." ALLEGED ISSUE REPORTED AS OCCURRED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT WAS REPORTED.