FDA.reportPublic FDA data

MAUDE MDR 9717758

MDR report key
9717758
Report number
1221084-2020-00009
Event key
0
Event type
3
Date of event
2020-02-05
Date received
2020-02-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. KEVIN BULLOCK
Address
300 DUKE DRIVE LEBANON, TN US
Phone
736-736-7360
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PERMOBIL F3POWERED WHEELCHAIRPERMOBIL INC.ITIF3N/AN/AN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1701. H

Event Narratives#

N

Patient 1

REPORTS PROVIDED TO PERMOBIL CLAIM THE END-USER WAS DRIVING THEIR DEVICE AT FULL SPEED WHEN THEY INADVERTENTLY CONTACTED AN IMMOVEABLE OBJECT WITH THE JOYSTICK. REPORTS CLAIM THE IMPACT WAS STRONG ENOUGH TO SIGNIFICANTLY DAMAGE THE JOYSTICK, RENDERING THE DEVICE INOPERABLE. REPORTS INDICATE THE END-USER WAS TAKEN TO THE HOSPITAL WITH UNDISCLOSED INJURIES. FURTHER ATTEMPTS TO GAIN INFORMATION AS TO EXTENT OF INJURY HAVE BEEN UNSUCCESSFUL WITH LATEST REPORTS INDICATING THE END-USER BEING TRANSFERRED INTO A SKILLED FACILITY FOR THE INTERIM. SERVICE PROVIDER REPORTS BEING INFORMED BY STAFF MEMBERS OF THE ASSISTED LIVING FACILITY OF THE EVENT BEING CAUSED BY THE END-USER IN THEIR FAILURE TO REDUCE SPEED WHEN NEGOTIATING A NARROW AREA. THERE WERE NO ALLEGATIONS OR CLAIMS MADE INDICATING THE DEVICE MALFUNCTIONED OR DEVIATED IN ANY WAY TO HAVE CONTRIBUTED TO THIS EVENT. REVIEW OF THE DHR SHOWS THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

D

Patient 1

RECEIVED REPORT STATING AS END-USER WAS DRIVING AT FULL SPEED, THEY INADVERTENTLY COLLIDED WITH AN OBJECT IMPACTING THE JOYSTICK CONTROL. THIS IMPACT REPORTEDLY CAUSED AN UNSPECIFIED INJURY TO THE END-USER REQUIRING MEDICAL INTERVENTION AND HOSPITALIZATION.