LUGGIE SCOOTER FR168-4 (IT)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-26 for LUGGIE SCOOTER FR168-4 (IT) manufactured by Freerider Corp..

Event Text Entries

[3618913] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008786141-2013-00002
MDR Report Key3267292
Date Received2013-07-26
Date of Report2013-07-26
Date of Event2013-07-11
Date Added to Maude2013-08-08
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street8696 UTICA AVE
Manufacturer CityRANCHO CUCAMONGA CA 917300000
Manufacturer CountryUS
Manufacturer Postal917300000
Manufacturer G1LUGGIE SCOOTER INC.
Manufacturer Street8696 UTICA AVE
Manufacturer CityRANCHO CUCAMONGA CA 91730000
Manufacturer CountryUS
Manufacturer Postal Code91730 0000
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLUGGIE SCOOTER
Generic NameLUGGIE SCOOTER
Product CodeKNL
Date Received2013-07-26
Model NumberFR168-4 (IT)
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Sequence No1
Device Event Key0
ManufacturerFREERIDER CORP.
Manufacturer AddressNO. 22, BENGONG 5TH RD. GANGSHAN DIST., KAOHSIUNG CITY 820 TW 820


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-07-26

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