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 2017-12-04 for OAE PEDIATRIC FOAM EAR TIPS 203211 manufactured by Natus Medical Inc..

Event Text Entries

[94796696] The customer was provided replacement foam tips, and product returns have been requested. 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.
Patient Sequence No: 1, Text Type: N, H10


[94796697] The customer reported to natus medical that the foam tips of the pediatric foam ear tips are separating from the inner plastic tubing. The customer has also reported glue inside the inner tubing. There has been no report of patient death, injury or delay in patient treatment. No environmental or safety concerns have also been reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3018859-2017-01012
MDR Report Key7081404
Report SourceUSER FACILITY
Date Received2017-12-04
Date of Report2017-11-07
Date Mfgr Received2018-08-01
Device Manufacturer Date2017-05-02
Date Added to Maude2017-12-04
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 INC.
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 Received2017-12-04
Model Number203211
Lot NumberN050217-05
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INC.
Manufacturer Address5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-12-04

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