MAUDE Adverse Event Report: DIGITAL IMAGING; MAMMOGRAM

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).

• Brand Name: DIGITAL IMAGING
• Type of Device: MAMMOGRAM
• MDR Report Key: 6046782
• MDR Text Key: 58180326
• Report Number: MW5065542
• Device Sequence Number: 1
• Product Code: LLZ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 85