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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RALON MEDICAL EQUIPMENT CO., LTD. ROSCOE; VOYAGER ROLLATOR
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RALON MEDICAL EQUIPMENT CO., LTD. ROSCOE; VOYAGER ROLLATOR Back to Search Results
Model Number RLEU10PK
Device Problem Fracture (1260)
Patient Problems Hematoma (1884); Vertebral Fracture (4520)
Event Date 03/03/2022
Event Type  Injury  
Event Description
Per end-user: states that she was sitting in her walker, tying her shoe, when the front right wheel came off the walker and she fell backwards hitting the pavement.She was taken to the er.Walker fell backwards on back of concrete at (b)(6).Had a hematoma and broke my tailbone.I was upside down on the pavement, 5 strangers helped me up and called 911 for ambulance.Put rollator in my car.Went to emergency room on (b)(6) 2022.In er for 7 hours.Dizzy spells.Dizzy when i stand up.Hurt back and head.Being rechecked on (b)(6) 2022.Must sleep on my side now.Indicated sometimes the wheel on the rollator looked like it was spinning.
 
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Brand Name
ROSCOE
Type of Device
VOYAGER ROLLATOR
Manufacturer (Section D)
RALON MEDICAL EQUIPMENT CO., LTD.
xilian development zone
jinsha, danzao town
foshan guangdong, 52822 2
CH  528222
MDR Report Key14053173
MDR Text Key288874879
Report Number3012316249-2022-00006
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberRLEU10PK
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/08/2022
Distributor Facility Aware Date03/18/2022
Device Age18 MO
Date Report to Manufacturer04/08/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/08/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexFemale
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