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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

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MENTOR SALINE BREAST IMPLANTS Back to Search Results
Event Date 03/30/2010
Event Type  Malfunction  
Event Description

I had saline breast implants in 2007. I've had symptoms of depression, anxiety, fatigue, hair loss, back and neck pain, pain in my breast, joint pain, numbness in my hands and arms, swallowing problems with chocking, unk rashes, and hormone imbalance caused hysterectomy (b)(6) 2016.

 
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Brand NameSALINE BREAST IMPLANTS
Type of DeviceSALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6636363
Report NumberMW5070366
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 06/08/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/08/2017
Is This An Adverse Event Report? No
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: 06/08/2017 Patient Sequence Number: 1
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