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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MEMORY GEL SMOOTH SILICONE

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MENTOR WORLDWIDE LLC MEMORY GEL SMOOTH SILICONE Back to Search Results
Event Date 09/09/2015
Event Type  Injury  
Event Description

Had breast augmentation in (b)(6) 2013. I was implanted with mentor memory gel silicone breast implants. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all that's happened. Now i am homeless. Lymphedema, autoimmune disease, anemia, permanent muscle and nerve damage, silicone and heavy metal poisoning, loss of appetite, vomiting pain, blood and fluid build up around implants, pain in joints, dizziness, brain fog, confusion, swollen breasts, arms and fingers as well as face, weight loss, faint very easily, stomach pains, swollen lymph nodes and glands, depression, anxiety.

 
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Brand NameMEMORY GEL SMOOTH SILICONE
Type of DeviceMEMORY GEL SMOOTH SILICONE
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
MDR Report Key6568714
Report NumberMW5069797
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/12/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
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

Patient TREATMENT DATA
Date Received: 05/12/2017 Patient Sequence Number: 1
Treatment
AMOXICILLIN
OTC MEDS: SINGULAIR
RX MEDS: EFFEXOR 150 XR
TYLENOL 3
VITAMIN E
XANAX 50
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