OAE PEDIATRIC FOAM TIP 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 2018-04-13 for OAE PEDIATRIC FOAM TIP 203211 manufactured by Natus Medical Incorporated.

Event Text Entries

[105663115] Return of the defective oae pediatric foam tips was requested by natus, but they had already been discarded by the user. The complainant was provided replacement oae pediatric foam tips. Instructions for use provided with hearing devices compatible with oae pediatric foam tips state to not pinch the foam while attaching the ear tip onto the nozzle. For removing the foam ear tips, instructions state to not pull on the foam when removing the foam ear tips and caution that users may end up pulling the foam off the clear tube while the tube remains on the nozzle. Users are also instructed to remove, discard and replace probe tips before each test. Natus is investigating this issue through corrective actions at this time.
Patient Sequence No: 1, Text Type: N, H10


[105663116] Natus received a report that the entire portion of foam separated from the plastic tubing. The report concerned two oae pediatric foam tips from the same lot number. There was no report of death, serious injury, delay in treatment, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3018859-2018-00114
MDR Report Key7429548
Report SourceUSER FACILITY
Date Received2018-04-13
Date of Report2018-03-15
Date Mfgr Received2018-08-01
Device Manufacturer Date2017-03-22
Date Added to Maude2018-04-13
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 ContactJAMES FITZGERALD
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal98108
Manufacturer Phone2062685173
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 TIP
Generic NameOAE PEDIATRIC FOAM TIP
Product CodeGWJ
Date Received2018-04-13
Model Number203211
Lot NumberN032217-04
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORATED
Manufacturer Address5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-04-13

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