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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE IMPLANTS; SALINE BREAST IMPLANTS
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MENTOR SALINE IMPLANTS; SALINE BREAST IMPLANTS Back to Search Results
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Arthritis (1723); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Myalgia (2238); Anxiety (2328); Complaint, Ill-Defined (2331); Impaired Healing (2378); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Lethargy (2560); Weight Changes (2607); No Code Available (3191)
Date of Event 01/02/2017
Type of Reportable Event Serious Injury
Event or Problem Description
I couldn't pick a date as i have been sick from my mentor saline implants since 2014.And continue to get sick today.I got my implants in 2010.Started showing symptoms in 2012.Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues.Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities.Inflammation, hoarse voice and throat clearing, hair loss, alcohol intolerance, anxiety, fatigue, muscle pain, insomnia.Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel.
 
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Brand Name
SALINE IMPLANTS
Common Device Name
SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7181726
Report NumberMW5074531
Device Sequence Number17261283
Product Code FWM
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 01/09/2018
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? No
Operator of Device Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/10/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Disability;
Patient Age42 YR
Patient Weight82
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