INVACARE PERFECTO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-12 for INVACARE PERFECTO manufactured by Invacare.

MAUDE Entry Details

Report NumberMW5091018
MDR Report Key9316062
Date Received2019-11-12
Date of Report2019-11-11
Date of Event2019-06-26
Date Added to Maude2019-11-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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 Sequence Number: 1

Brand NameINVACARE PERFECTO
Generic NameGENERATOR, OXYGEN, PORTABLE
Product CodeCAW
Date Received2019-11-12
Returned To Mfg2019-06-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerINVACARE
Manufacturer AddressUS

Device Sequence Number: 2

Brand NameINVACARE PERFECTO
Generic NameGENERATOR, OXYGEN, PORTABLE
Product CodeCAW
Date Received2019-11-12
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerINVACARE
Manufacturer AddressUS

Device Sequence Number: 3

Brand NameINVACARE PERFECTO
Generic NameGENERATOR, OXYGEN, PORTABLE
Product CodeCAW
Date Received2019-11-12
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerINVACARE
Manufacturer AddressUS

Device Sequence Number: 4

Brand NameINVACARE PERFECTO
Generic NameGENERATOR, OXYGEN, PORTABLE
Product CodeCAW
Date Received2019-11-12
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerINVACARE
Manufacturer AddressUS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-12

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