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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS
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MENTOR BREAST IMPLANTS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Headache (1880); Loss of Range of Motion (2032); Staphylococcus Aureus (2058); Swelling (2091); Swollen Lymph Nodes (2093); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Burning Sensation (2146); Myalgia (2238); Anxiety (2328); Depression (2361); Numbness (2415); Cognitive Changes (2551)
Event Date 02/01/2007
Event Type  Injury  
Event Description
Had breast augmentation done.I have had recurrent bacterial vaginosis, uti's, black-ish green discharge form breast nipples (tested and came back as staph infection).Now i have white-ish pus discharge (fungal infection), extreme pain/burning in both breasts as well as numbness/tingling/burning sensation in arms/shoulder, grade #4 capsular, contracture, trouble breathing properly, memory loss/brain fog, blurry vision, swollen throat lymph nodes, loss of motion in both arms, major teeth issues due to implants, leaky gut/ibs, extreme anxiety and depression, bed ridden, muscle pain, unknown opage spots on breast ultrasound, candida issues/fungal issues/bacterial issues, muscle loss, extremely achy joints, massive fatigue, sinus issues, migraines.
 
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Brand Name
BREAST IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6348976
MDR Text Key68150944
Report NumberMW5068004
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/17/2017
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 Received02/17/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
DILAUDID; FLUCONAZOLE; LAMISIL; METRONIDAZOLE; NYSTATIN; OTC MEDS: IBUPROFEN; PROBIOTICS; REMERON; RX MEDS: FENTANYL; XANAX
Patient Outcome(s) Life Threatening; Other; Required Intervention; Disability;
Patient Age43 YR
Patient Weight45
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