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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hair Loss (1877); Pain (1994); Rash (2033); Anxiety (2328); Depression (2361); Choking (2464); No Code Available (3191)
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 Name
SALINE BREAST IMPLANTS
Type of Device
SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6636363
MDR Text Key77559319
Report NumberMW5070366
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 06/08/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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 Received06/08/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age43 YR
Patient Weight67
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