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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SALINE IMPLANTS

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MENTOR SMOOTH SALINE IMPLANTS Back to Search Results
Lot Number 6425763
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Anxiety (2328); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Event Date 06/01/2015
Event Type  Injury  
Event Description
In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants.Over the next 6 years i began to experience various symptoms such as daily headaches, insomnia, anxiety, and brain fog that i just wrote off at the time.By the summer of 2015 my health had took a turn for the worse.I became bedridden and only made attempts to get up to see another doctor to just get no answers to my sudden health decline that felt like i was dying some days.
 
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Brand Name
SMOOTH SALINE IMPLANTS
Type of Device
SMOOTH SALINE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6456465
MDR Text Key71768409
Report NumberMW5068879
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/31/2017
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
Device Lot Number6425763
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/31/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
ADDERALL; D3; EPSOM SALT SOAKS; MAGNESIUM; OTC MEDS: NIACIN; PROBIOTIC; RX MEDS: EFFEXOR; VALIUM
Patient Outcome(s) Hospitalization;
Patient Age26 YR
Patient Weight61
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