FDA.reportPublic FDA data

MAUDE MDR 7037691

MDR report key
7037691
Report number
3018859-2017-00915
Event key
0
Event type
3
Date received
2017-11-16
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
JIM FITZGERALD
Address
5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US
Phone
561-561-5613
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OAE PEDIATRIC FOAM EAR TIPSOAE PEDIATRIC FOAM EAR TIPSNATUS MEDICAL INC.GWJ203211N031717-03N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-1601. O

Event Narratives#

N

Patient 1

THE CUSTOMER WAS PROVIDED REPLACEMENT FOAM TIPS. NATUS INSTRUCTIONS INCLUDE SELECTING THE APPROPRIATE SIZE EAR TIP FOR THE PATIENT, AS WELL AS INSTRUCTIONS REGARDING USING LARGER SIZE FOAM TIPS FOR INSERTION INTO THE EAR CANAL. NATUS IS INVESTIGATING THIS ISSUE THROUGH CORRECTIVE ACTIONS AT THIS TIME.

D

Patient 1

THE CUSTOMER REPORTED TO NATUS MEDICAL THAT THE FOAM TIPS OF THE PEDIATRIC FOAM EAR TIPS ARE SEPARATING FROM THE PLASTIC TUBING. THERE HAS BEEN NO REPORT OF PATIENT DEATH, INJURY OR DELAY IN PATIENT TREATMENT. NO ENVIRONMENTAL OR SAFETY CONCERNS HAVE ALSO BEEN REPORTED.