BLOOD PRESSURE MACHINE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for BLOOD PRESSURE MACHINE manufactured by Unk.

MAUDE Entry Details

Report NumberMW5090104
MDR Report Key9134827
Date Received2019-09-27
Date of Report2019-09-20
Date Added to Maude2019-09-30
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 Use0
Previous Use Code0
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameBLOOD PRESSURE MACHINE
Generic NameSYSTEM, MEASUREMENT, BLOOD PRESSURE, NONINVASIVE
Product CodeDXN
Date Received2019-09-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 2

Brand NameLARGE CUFF
Generic NameBLOOD PRESSURE CUFF
Product CodeDXN
Date Received2019-09-27
Device Availability*
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 3

Brand NameSMALL CUFF
Generic NameBLOOD PRESSURE CUFF
Product CodeDXN
Date Received2019-09-27
Device Availability*
Device Sequence No3
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-27

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