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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCALE SCALE, PATIENT

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SCALE SCALE, PATIENT Back to Search Results
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2017
Event Type  Injury  
Event Description
I was donating plasma and there's a new electronic system. I was deferred weighing in at (b)(6) but they weighed me in the next room and i weighed (b)(6). I weighed myself previously that morning before going and i was (b)(6). This is the 2nd time this week i have been deferred. I have lost out on (b)(6) and i believe now i do not qualify for my bonus because of the inaccurate scale and the new system.
 
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Brand NameSCALE
Type of DeviceSCALE, PATIENT
MDR Report Key6515633
MDR Text Key73600270
Report NumberMW5069262
Device Sequence Number1
Product Code FRW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/20/2017 Patient Sequence Number: 1
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