PERMOBIL M300 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-14 for PERMOBIL M300 N/A manufactured by Permobil Inc..

Event Text Entries

[184112527] Reports provided claim as the end-user was operating the power leg function of the seating, at one point they felt the footplate lift up, presumably from contacting the caster. This action caused the end-user to panic and for reasons they could not explain, grabbed the joystick knob and accelerated forward. When doing this, they continued to drive until colliding with the edge of a transfer board. This collision impacted their leg, reportedly inducing a laceration to their left calf requiring medical intervention. End-user reported being hospitalized for 5 weeks, requiring staples and skin grafts. Service provider reports having inspected the device and found it to be fully operational with no mechanical issues being noted. The end-user fully admitted the accident was their fault as they panicked. End-user reported they were not driving the chair when the footplate allegedly contacted the footplate, only after feeling their foot move upward did they have the urge of panic and thus drove the device. No allegations were made that the device operated abnormally to have caused this event. The dhr was reviewed and device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10


[184112528] Received report claiming as end-user was operating seat functions, one of the footplates contacted a caster wheel which caused the end-user to panic. Reports indicate while in their panicked state, they grabbed the joystick and drove forward until the device collided into an unspecified object. Reports claim the end-user suffered serious injuries requiring medical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221084-2020-00008
MDR Report Key9711470
Report SourceDISTRIBUTOR
Date Received2020-02-14
Date of Report2020-02-14
Date of Event2019-11-15
Date Mfgr Received2020-01-24
Device Manufacturer Date2017-02-28
Date Added to Maude2020-02-14
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 DR.
Manufacturer CityLEBANON, TN
Manufacturer CountryUS
Manufacturer Phone7360925451
Manufacturer G1PERMOBIL INC.
Manufacturer Street300 DUKE DR.
Manufacturer CityLEBANON, TN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERMOBIL M300
Generic NamePOWER WHEELCHAIR
Product CodeITI
Date Received2020-02-14
Model NumberM300
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 DR. LEBANON, TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-02-14

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