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MAUDE Adverse Event Report:; KNEE SCOOTER
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; KNEE SCOOTER
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Device Problem
Unstable (1667)
Patient Problem
Fall (1848)
Event Type
Injury
Event Description
The end-user was in the bathroom, when the brake gave out on the knee scooter, and she was injured.
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Type of Device
KNEE SCOOTER
MDR Report Key
6675453
MDR Text Key
78657889
Report Number
3012316249-2017-00076
Device Sequence Number
1
Product Code
ITJ
Combination Product (y/n)
N
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Distributor
Reporter Occupation
Other
Type of Report
Initial
Report Date
06/28/2017
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
Was Device Available for Evaluation?
No
Is the Reporter a Health Professional?
No
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
06/28/2017
Distributor Facility Aware Date
06/02/2017
Event Location
Home
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
06/28/2017
Is This a Reprocessed and Reused Single-Use Device?
No
Type of Device Usage
N
Patient Sequence Number
1
Patient Outcome(s)
Other;
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