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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIGITAL IMAGING MAMMOGRAM

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DIGITAL IMAGING MAMMOGRAM Back to Search Results
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Between (b)(6) 2014 to (b)(6) 2016, mammogram results: possibly were erroneous. Located in (b)(6).
 
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Brand NameDIGITAL IMAGING
Type of DeviceMAMMOGRAM
MDR Report Key6046782
MDR Text Key58180326
Report NumberMW5065542
Device Sequence Number1
Product Code LLZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/18/2016 Patient Sequence Number: 1
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