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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Syncope (1610); Abdominal Pain (1685); Anemia (1706); Autoimmune Disorder (1732); Nerve Damage (1979); Pain (1994); Swelling (2091); Vomiting (2144); Dizziness (2194); Anxiety (2328); Toxicity (2333); Arthralgia (2355); Depression (2361); Confusion/ Disorientation (2553); Weight Changes (2607)
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 Name
MEMORY GEL SMOOTH SILICONE
Type of Device
MEMORY GEL SMOOTH SILICONE
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
MDR Report Key6568714
MDR Text Key75325379
Report NumberMW5069797
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/12/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
AMOXICILLIN; OTC MEDS: SINGULAIR; RX MEDS: EFFEXOR 150 XR; TYLENOL 3; VITAMIN E; XANAX 50
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age28 YR
Patient Weight48
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