FDA Adverse Event Injury Summary report: N

SMARTDRIVE

MDR report key: 20251721 · Received September 18, 2024

Report

Report Number: 3008370857-2024-00012
Event Type: Injury
Date Received: September 18, 2024
Date of Event: August 28, 2024
Report Date: September 18, 2024
Manufacturer: MAX MOBILITY LLC
Product Code: ITI
UDI-DI: 00861896000310
PMA / PMN Number: K151199
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE END-USER REPORTS THERE IS NO PHYSICAL DAMAGES TO THE SPEED CONTROL DIAL, BUT REPORTS THE WAY IT IS MOUNTED ON THEIR WHEELCHAIR FRAME, IT IS IN THE WAY WHENEVER THEY TRANSFER. REPORT CLAIMS AS THE END-USER WAS TRANSFERRING INTO THEIR CAR, THEIR LEG WAS RESTING ATOP THE SPEED DIAL AND WHEN THEY SLID ACROSS, THEY RECEIVED A LARGE GASH ON THE UNDERSIDE OF THEIR RIGHT THIGH THAT REQUIRED 8 STAPLES AND 2 STICHES. THE END-USER STATED THERE AREN'T ANY DAMAGES TO THE DIAL, BUT THEY WILL NO LONGER UTILIZE THE CONTROL UNTIL A BETTER MOUNTING POINT CAN BE IDENTIFIED. REVIEW OF PHOTO EVIDENCE PROVIDED BY THE END-USER APPEARS TO CONFIRM NO DAMAGES TO THE DIAL WERE PRESENT. WITH THE INFORMATION PROVIDED, PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO PROBABLE ROOT CAUSE WITHOUT SPECULATION. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

Description of Event or Problem · 0

REPORTS WHILE TRANSFERRING FROM THE MANUAL WHEELCHAIR INTO THEIR CAR, THE END-USER REPORTS THEIR LEG WAS CAUGHT ON THE SPEED CONTROL DIAL AND REPORTEDLY INJURED THEIR LEG REQUIRING MEDICAL INTERVENTION TO ADDRESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2526576	SMARTDRIVE	SMARTDRIVE	ITI	MAX MOBILITY LLC	MX2+	N/A	00861896000310

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Prefer Not To Disclose	Hospitalization