UNIVERSAL BITE BLOCK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for UNIVERSAL BITE BLOCK manufactured by B&b Medical Technologies, Inc..

MAUDE Entry Details

Report NumberMW5090706
MDR Report Key9245094
Date Received2019-10-25
Date of Report2019-10-09
Date of Event2019-07-30
Date Added to Maude2019-10-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNIVERSAL BITE BLOCK
Generic NameSUPPORT, BREATHING TUBE
Product CodeJAY
Date Received2019-10-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerB&B MEDICAL TECHNOLOGIES, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-25

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