PERMOBIL M3 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for PERMOBIL M3 N/A manufactured by Permobil Inc..

MAUDE Entry Details

Report Number1221084-2020-00016
MDR Report Key9868241
Report SourceCONSUMER
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-22
Date Mfgr Received2020-02-25
Device Manufacturer Date2019-12-27
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. KEVIN BULLOCK
Manufacturer Street300 DUKE DRIVE
Manufacturer CityLEBANON, TN
Manufacturer CountryUS
Manufacturer Phone7360925451
Manufacturer G1PERMOBIL INC.
Manufacturer Street300 DUKE DRIVE
Manufacturer CityLEBANON, TN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERMOBIL M3
Generic NamePOWERED WHEELCHAIR
Product CodeITI
Date Received2020-03-23
Model NumberM3
Catalog NumberN/A
Lot NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPERMOBIL INC.
Manufacturer Address300 DUKE DRIVE LEBANON, TN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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