MEDISORB M1173311

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for MEDISORB M1173311 manufactured by Vyaire Medical Oy.

Event Text Entries

[184156482] Product defect discovered during anesthesia pre-check. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093730
MDR Report Key9829048
Date Received2020-03-12
Date of Report2020-03-10
Date of Event2020-03-10
Date Added to Maude2020-03-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDISORB
Generic NameABSORBER CARBON-DIOXIDE
Product CodeBSF
Date Received2020-03-12
Model NumberM1173311
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL OY
Manufacturer AddressHELSINKI, FN FI


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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