FDA.reportPublic FDA data

MAUDE MDR 8306492

MDR report key
8306492
Report number
3004365956-2019-00033
Event key
0
Event type
3
Date of event
2019-01-21
Date received
2019-02-05
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,ELONG,ADULTMASK, OXYGENTELEFLEX MEDICALBYG104174F1800153Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-050

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 OF BATCH NUMBER REPORTED HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. TO PERFORM A PROPER AND THOROUGH INVESTIGATION, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED. ALTHOUGH THIS COMPLAINT COULD NOT BE CONFIRMED, BASED ON TRENDING SIMILAR CUSTOMER COMPLAINTS FOR THIS DEVICE, A CAPA REQUEST HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. 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. THEREFORE, A NEW PACKAGE WAS USED INSTEAD." NO PATIENT INJURY WAS REPORTED. PATIENT CONDITION REPORTED AS FINE.