MAUDE Adverse Event Report: MAMMOGRAPHY MACHINE

Device Problems Device Reprocessing Problem (1091); Use of Device Problem (1670)

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

Event Date 03/10/2016

Event Type  malfunction  

Event Description

Patient had 2 previous mammographies in 2009 and 2010 respectively, so she knew the procedure.On (b)(6) 2016, she went to (b)(6) radiology, situated at (b)(6).When patient was in her gown, she walked to the machine.Right there the tech called (b)(6), didn't even acknowledge her.The machine appeared very dirty.She inquired about this from the technician who curtly remarked that she cleans the machine after every use.During the procedure, as patient stiffened her body and drew closer to the board, she saw unmistakable smudges, greasy body fluids, etc.On the machine.When she showed these to the tech, her response was, "it's just the wear of the glass".From then the tech took total control and was very uncooperative.She placed her hand on patient's shoulder, pushed her to be adjusted to the machine, and rudely said, "bend your knees".In the 2 prior mammograms patient had done, the techs had adjusted the machine to fit the patient.In this case the contrary was true.The tech got the patient to meet the machine.She never moved the machine.As the procedure continued, the tech's finger was right on the patient's nipple.Normally a piece of cotton or tissue pad is placed on the patient's nipple.It wasn't the case here.The tech continued touching the tip of the patient's nipple a few more times.After the 5th touch, patient told the tech that she didn't want to be touched.Tech said "nipples are the most important part of the mammogram".The tech kept touching the nipple and didn't even try to avoid it.This went on about 10 more times.Patient eventually reported the matter to the (b)(6).On (b)(6) 2016, she received a letter from the state inspector stating that they investigated the matter and found nothing wrong.Patient is now considering legal action against the tech.

• Brand Name: MAMMOGRAPHY MACHINE
• Type of Device: MAMMOGRAPHY MACHINE
• MDR Report Key: 5670960
• MDR Text Key: 45786166
• Report Number: MW5062395
• 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: Other
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR