E-A-RLINK EARTIP 420-2006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for E-A-RLINK EARTIP 420-2006 manufactured by 3m.

MAUDE Entry Details

Report NumberMW5087523
MDR Report Key8722950
Date Received2019-06-20
Date of Report2019-05-24
Date of Event2019-05-22
Date Added to Maude2019-06-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameE-A-RLINK EARTIP
Generic NameCUSHION, EARPHONE (FOR AUDIOMETRIC TESTING)
Product CodeETT
Date Received2019-06-20
Model Number420-2006
Catalog Number420-2006
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
Manufacturer3M


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-20

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