OAE PEDIATRIC FOAM EAR TIPS 203211

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-28 for OAE PEDIATRIC FOAM EAR TIPS 203211 manufactured by Natus Medical Incorporated.

Event Text Entries

[93572012] A replacement part was sent, resolving customer issue. Natus has requested the affected lot containing the foam tips for further investigation of this complaint. 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. Supplemental report will be submitted as needed.
Patient Sequence No: 1, Text Type: N, H10


[93572013] Natus medical received a complaint on (b)(6) 2017. That their oae pediatric foam tip that have foam that is seperating from the tube before insertion into the ear. The customer confirmed that there was no death/serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3018859-2017-00974
MDR Report Key7065425
Report SourceUSER FACILITY
Date Received2017-11-28
Date of Report2017-11-01
Date Mfgr Received2018-08-01
Date Added to Maude2017-11-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJIM FITZGERALD
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal98108
Manufacturer Phone5613065818
Manufacturer G1NATUS MEDICAL INCORPORATED
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal Code98108
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOAE PEDIATRIC FOAM EAR TIPS
Generic NameOAE PEDIATRIC FOAM EAR TIPS
Product CodeGWJ
Date Received2017-11-28
Model Number203211
Lot NumberN032217-04
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORATED
Manufacturer Address5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-28

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