MAUDE Adverse Event Report: MAMMOGRAM; SYSTEM IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016: yearly mammogram with (b)(6).On (b)(6): call back of abnormal mammogram and need for repeat mammogram and ultrasound.First appointment available three weeks later.On (b)(6): called to see if i could get an earlier appointment, i was told that "my study" did not have an appt until (b)(6).When i asked, "what study," told that study request was wrong but still the only available appt was (b)(6).On (b)(6): f/u mammogram/ultrasound appt.After 2.5 hr wait, finally got mammogram and ultrasound finished.Doctor got results (very small area, come back in six months; i received the result letter from professional imaging two months later.In (b)(6) 2017 - requested all images on file to bring to (b)(6).Told at time there was a possibly that all their films from 2016 were missing.Called back five days later, and i was told images were found and would be sent.On (b)(6): new mammogram/ultrasound at (b)(6).When i arrived, i was told that professional imaging that had only sent (b)(6) left breast image.Small (7mm) area found; told to come back in six months.Felt professional imaging was very unprofessional.Wanted to go on record with my difficulties as it appears my story is not unique to pts using professional imaging for mammograms/breast checks.Staff was wonderful, but wait time and follow through terrible.

• Brand Name: MAMMOGRAM
• Type of Device: SYSTEM IMAGING
• MDR Report Key: 6621526
• MDR Text Key: 77277766
• Report Number: MW5070250
• Device Sequence Number: 1
• Product Code: IZH
• 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: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 68