FDA Adverse Event Injury Summary report: N

SMARTDRIVE

MDR report key: 22895620 · Received August 26, 2025

Report

Report Number: 3008370857-2025-00200
Event Type: Injury
Date Received: August 26, 2025
Date of Event: July 24, 2025
Report Date: August 26, 2025
Manufacturer: MAX MOBILITY LLC
Product Code: ITI
UDI-DI: 00861896000310
PMA / PMN Number: K151199
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

PERMOBIL RECEIVED REPORT CLAIMING WHILE THE END-USER WAS MOWING THEIR YARD WHILE OPERATING THE SMARTDRIVE MX2+ DEVICE VIA THE SPEED CONTROL DIAL, THEY REPORTED HAVING ATTEMPTED TO STOP THE DEVICE VIA THE SPEED CONTROL DIAL, BUT CLAIMS THE MOTOR CONTINUED TO RUN. END-USER CLAIMS HAVING RIPPED THE CABLE OUT OF THE DIAL BUT CONTESTS THE SMARTDRIVE DEVICE CONTINUED TO RUN. THIS REPORTED RESULTED WITH THE END-USER'S FEET TO MAKE CONTACT WITH THE MOWER BLADES. END-USER WAS REPORTED TO HAVE BEEN TAKEN TO THE HOSPITAL WHERE SURGERY WAS REQUIRED TO AMPUTATE TOES FROM THE USER'S FOOT. AT THIS TIME, PERMOBIL NOR THE PROVIDER HAVE BEEN ABLE TO INSPECT THE DEVICE OR IT'S CONTROLLER. PERMOBIL IS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE AS YET. IF PERMOBIL RECEIVES ANY NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

Description of Event or Problem · 0

RECEIVED REPORT CLAIMING WHILE THE END-USER WAS MOWING THEIR YARD WHILE UNDER POWER OF THE SMARTDRIVE DEVICE VIA A SPEED CONTROL DIAL, THE END-USER REPORTEDLY ATTEMPTED TO DISENGAGE DRIVE AND REPORTS THE SMARTDRIVE CONTINUED TO RUN. REPORTS INDICATE THE END-USERS FOOT CONTACTED THE MOWER RESULTING IN A SERIOUS INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1866448	SMARTDRIVE	SMARTDRIVE	ITI	MAX MOBILITY LLC	MX2+		00861896000310

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Hospitalization\| S