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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547; WALKER, MECHANICAL
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UNKNOWN ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547; WALKER, MECHANICAL Back to Search Results
Model Number 65650
Device Problem Detachment Of Device Component (1104)
Patient Problem Discomfort (2330)
Event Type  Injury  
Event Description
The dealer states that the daughter of the patient called yesterday and states that the wheel just fell off of the rollator.Update (b)(6) 2015: consumer¿s sister states that her sister sustained a head and hip injury because she fell of the rollator onto the floor.She hit her head and her hip on the floor.Her sister states 911 was called, but her sister refused to be transported to the hospital at that time.When she was still having soreness in her hip days later, she contacted her doctor, he ordered x-rays.Her sister states they have not yet received the results.
 
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Brand Name
ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
UNKNOWN
OH
MDR Report Key4815732
MDR Text Key21559223
Report Number1531186-2015-01033
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
Source Type Invalid Data
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/01/2015,05/27/2015
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 Number65650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2015
Distributor Facility Aware Date05/27/2015
Date Report to Manufacturer06/01/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/03/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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