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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT ROLLATOR 9153651315; WALKER, MECHANICAL

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DANYANG MAXTHAI MEDICAL EQUIPMENT ROLLATOR 9153651315; WALKER, MECHANICAL Back to Search Results
Model Number 65650
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problems Discomfort (2330); Injury (2348)
Event Type  Injury  
Event Description
The caller states the consumer sat on the seat and the front wheel collapsed and dumped the consumer on the floor.The caller states the consumer weighs about (b)(6) pounds.The caller states the consumer was sore after the fall and they did mri to check for injuries and was confirmed no injury internal.The caller did state the consumer is still sore.
 
Manufacturer Narrative
Product was returned for evaluation.The return fields in oracle state: rollators.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the rollator collapsing.The front right caster was observed to be unable to attach properly due to damaged threading.Complaint was confirmed.The underlying cause is damaged threading.Root cause could not be determined after reviewing the documentation in this investigation.
 
Event Description
Product was returned for evaluation.The return fields in oracle state: rollators.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the rollator collapsing.The front right caster was observed to be unable to attach properly due to damaged threading.The caller states the consumer sat on the seat and the front wheel collapsed and dumped the consumer on the floor.The caller states the consumer weighs about (b)(6).The caller states the consumer was sore after the fall and they did mri to check for injuries and was confirmed no injury internal.The caller did state the consumer is still sore.
 
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Brand Name
ROLLATOR 9153651315
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
DANYANG MAXTHAI MEDICAL EQUIPMENT
danyang
CH 
MDR Report Key5563936
MDR Text Key42346825
Report Number1531186-2016-00010
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 04/07/2016,04/19/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/07/2016
Distributor Facility Aware Date04/19/2016
Device Age27 MO
Date Report to Manufacturer04/07/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/08/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/21/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight109
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