GN RESOUND EY367 19542202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-21 for GN RESOUND EY367 19542202 manufactured by Gn Hearing A/s.

MAUDE Entry Details

Report Number3005650109-2019-00006
MDR Report Key8914309
Report SourceHEALTH PROFESSIONAL
Date Received2019-08-21
Date of Report2019-08-19
Date of Event2018-12-01
Date Mfgr Received2019-05-27
Device Manufacturer Date2018-05-25
Date Added to Maude2019-08-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR LARS HAGANDER
Manufacturer StreetLAUTRUPBJERG 7 P.O. BOX 130
Manufacturer CityBALLERUP, COPENHAGEN 2750
Manufacturer CountryDA
Manufacturer Postal2750
Manufacturer G1GN HEARING A/S
Manufacturer StreetLAUTRUPBJERG 7 P.O. BOX 130
Manufacturer CityBALLERUP, 2750
Manufacturer CountryDA
Manufacturer Postal Code2750
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGN RESOUND
Generic NameENYA GN RESOUND
Product CodeOSM
Date Received2019-08-21
Returned To Mfg2019-06-13
Model NumberEY367
Catalog Number19542202
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGN HEARING A/S
Manufacturer AddressLAUTRUPBJERG 7 BALLERUP, 2750 DA 2750


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-08-21

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