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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIGITAL MAMMOGRAM DIGITAL MAMMOGRAM

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DIGITAL MAMMOGRAM DIGITAL MAMMOGRAM Back to Search Results
Event Date 11/05/2015
Event Type  Injury  
Event Description

Had mammogram at (b)(6) hospital and became very ill within 3 weeks. I had silicone breast implants and had no idea they both got ruptured. I started in (b)(6) going to doctor. Unable to walk. Severe pain in feet. Many test to follow. Was sent to podiatrist and rheumatologist. Was immediately put on meloxicam for inflammation. Tested positive ana for possible lupus. Had many blood test and i have all of the results. As of(b)(6) i no longer was able to work. Diagnosed with mid foot osteoarthritis and surgery was suggested. I was also diagnosed with lower back osteoarthritis and in (b)(6) with fibro. I applied for social security disability and as approved. I did not correlate the breast implants till approx (b)(6). I requested an mri and it was shown both implants were ruptured. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. I got so sick so fast and did not know why. Since the removal of the implants, i have had 2 add'l reconstruction surgeries including a latissimus flap. I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. I have pictures, notes and many bills. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. The implants were silicone made by mentor 600cc.

 
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Brand NameDIGITAL MAMMOGRAM
Type of DeviceDIGITAL MAMMOGRAM
MDR Report Key7002916
Report NumberMW5073144
Device Sequence Number1
Product CodeLLZ
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/02/2017
3 DeviceS WERE Involved in the Event: 1   2   3  
0 PatientS WERE Involved in the Event:
Date FDA Received11/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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

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