FDA Adverse Event Injury Summary report: N

IBOT PMD

MDR report key: 22534784 · Received July 17, 2025

Report

Report Number: 3014522447-2025-00006
Event Type: Injury
Date Received: July 17, 2025
Date of Event: June 25, 2025
Report Date: July 17, 2025
Manufacturer: MOBIUS MOBILITY LLC.
Product Code: IMK
UDI-DI: 00857584008010
PMA / PMN Number: K210920
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BLACKBOX AND ECF DATA AND VIDEO WERE RETRIEVED AND EVALUATED. AS THE DEVICE DID NOT TIP OVER, AN EVENT LOG WAS NOT CREATED FOR THE INCIDENT. THERE WERE NO DIAGNOSTIC CODES PRESENT IN THE DATA, INDICATING THERE WERE NO ISSUES WITH THE IBOT® PMD AT THE TIME OF THE EVENT. THERE IS NO INDICATION THAT THE IBOT® PMD CONTRIBUTED TO THE INCIDENT, NOR IS THERE EVIDENCE OF ANY MALFUNCTION OR ISSUE WITH THE DEVICE AT THE TIME OF THE INCIDENT.

Description of Event or Problem · 0

THE USER WAS OPERATING THE IBOT® PMD IN A CROSSWALK IN 4-WHEEL MODE. THE USER BEGAN CROSSING THE STREET WHILE THE TRAFFIC SIGNAL WAS RED. WHEN SHE WAS ABOUT TO CROSS IN FRONT OF A SEMI-TRUCK FROM THE PASSENGER SIDE, THE TRAFFIC LIGHT CHANGED TO GREEN FOR VEHICLE TRAFFIC AND THE TRUCK BEGAN TO MOVE FORWARD. SURVEILLANCE FOOTAGE SHOWS THE USER WAVED HER ARM TO ATTEMPT TO GET THE DRIVER'S ATTENTION, BUT THE TRUCK DID NOT STOP. THE TRUCK COLLIDED WITH THE USER AT A FAIRLY LOW SPEED AND PUSHED HER ABOUT 15 FEET FURTHER INTO THE INTERSECTION. THE DEVICE DID NOT TIP OVER, AND THE USER REMAINED IN THE SEAT. THE USER SUSTAINED A SPRAINED KNEE AND ANKLE AND WAS BROUGHT TO THE HOSPITAL OUT OF AN ABUNDANCE OF CAUTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
764564	IBOT PMD	IBOT	IMK	MOBIUS MOBILITY LLC.	IBOT PMD	N/A	00857584008010

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR	Female	Hospitalization