MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hair Loss (1877); Pain (1994); Rash (2033); Anxiety (2328); Depression (2361); Choking (2464); No Code Available (3191)
Date of Event	03/30/2010
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: SALINE BREAST IMPLANTS
• Common Device Name: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6636363
• Report Number: MW5070366
• Device Sequence Number: 1405800
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 67