FDA Adverse Event Injury Summary report: N

LUGGIE SCOOTER

MDR report key: 3267292 · Received July 26, 2013

Report

Report Number
3008786141-2013-00002
Event Type
Injury
Date Received
July 26, 2013
Date of Event
July 11, 2013
Report Date
July 26, 2013
Manufacturer
FREERIDER CORP.
Product Code
KNL
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
TX, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

THE FOLLOWING INFORMATION WAS PROVIDED BY THE IMPORTER, (B)(4) DATED (B)(4) 2013. (B)(6) REPORTED SHE TIPPED OVER TWICE USING THIS PRODUCT AND SUFFERED A CONCUSSION. MRS (B)(6) REPORTED TO THE DEALER ((B)(4)) THAT SHE WAS TIPPED OVER WHEN USING THE LUGGIE SCOOTER AND SUFFERED A CONCUSSION. SHE WAS ON VACATION WITH HER HUSBAND ON (B)(6) 2013 IN (B)(6). HER HUSBAND WAS PLAYING ON A MACHINE AND SHE WAS RIDING THE SCOOTER TO GET TO HIM. SHE SAW SOMETHING BLACK (POSSIBLY FAINTED) AND THAT'S ALL SHE REMEMBERED UNTIL SHE WOKE UP. SHE BELIEVE WAS MAKING A TURN AT THE TIME. WHEN SHE WOKE UP, SHE SAW THE SECURITY GUARDS AND THEY HELPED HER INTO A WHEEL CHAIR. HER HUSBAND RODE THE LUGGIE TO ACCOMPANY HER TO THE BACK ROOM. SHE SAID SHE WAS BLEEDING ON THE BACK, TOP RIGHT PART OF HER HEAD. THE SECURITY GUARDS CALLED EMS, AND EMS WANTED TO GET HER TO THE EMERGENCY BUT HER HUSBAND WANTED TO LEAVE FIRST TO GO HOME AND GO TO THE EMERGENCY ROOM LATER. THE BLEEDING STOPPED WHILE THEY WERE THERE. SHE HAD HEADACHES EVER SINCE. (B)(6) WENT TO SEE HER DOCTOR ON (B)(6) 2013 AND THE DOCTOR GAVE HER A CAT SCAN. IODINE WAS ORDERED BUT NOT USED. (B)(6) IS CURRENTLY WAITING FOR THE RESULTS OF THE CAT SCAN. AS FAR AS (B)(6) CAN IDENTIFY, SHE WAS RIDING ON A FLAT SURFACE AT THE TIME OF EVENT. IT HAPPENED IN THE AFTERNOON. DOCTOR CONTACT INFORMATION: (B)(6). CUSTOMER IS LOOKING TO SPEAK WITH LAWYER FOR THE MEDICAL BILLS. (B)(6) WAS CONTACTED BY THE HEAD OF SECURITY FROM (B)(6) ON (B)(6) 2013 AND WAS TOLD THAT THEY HAVE THE RECORDING OF THE EVENT. ACCORDING TO DESCRIPTION FROM (B)(6), SHE WAS TURNING A CORNER AND BRUSHED UP AGAINST A WALKER. THIS MADE THE DEVICE UNSTABLE AND ROCKING. THE SCOOTER STARTED WOBBLING AND THIS CAUSED HER FALL. (B)(6) DOES NOT WANT TO RETURN THE SCOOTER AT THIS TIME. SHE WANTS TO DISCUSS WITH HER LAWYER FIRST. REFERENCE MFR # 3003820676-2013-00002.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
351566 LUGGIE SCOOTER LUGGIE SCOOTER KNL FREERIDER CORP. FR168-4 (IT)

Patients

Seq Age Sex Outcome Treatment
1 75 YR Other