B90 DIRECT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-19 for B90 DIRECT manufactured by Sonova Usa, Inc..

MAUDE Entry Details

Report NumberMW5091195
MDR Report Key9349065
Date Received2019-11-19
Date of Report2019-11-18
Date of Event2019-08-15
Date Added to Maude2019-11-20
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 Report0

Device Sequence Number: 1

Brand NameB90 DIRECT
Generic NameHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
Product CodeOSM
Date Received2019-11-19
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSONOVA USA, INC.

Device Sequence Number: 2

Brand NameB90 DIRECT
Generic NameHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
Product CodeOSM
Date Received2019-11-19
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerSONOVA USA, INC.

Device Sequence Number: 3

Brand NameB90 DIRECT
Generic NameHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
Product CodeOSM
Date Received2019-11-19
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerSONOVA USA, INC.

Device Sequence Number: 4

Brand NameMARVEL
Generic NameHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
Product CodeOSM
Date Received2019-11-19
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerSONOVA USA, INC.

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-19
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