MAUDE Adverse Event Report: MENTOR MENTOR SALINE TEXTURED BREAST IMPLANT; SALINE BREAST IMPLANTS

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Congenital Defect/Deformity (1782); Pain (1994); Swelling (2091); Electrolyte Imbalance (2196)
Date of Event	04/01/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
My child was born when i had breast implants and was diagnosed with sensory integration disorders.Pain, swallowing issues, skin issues, high calcium, low potassium, high copper, leg pains, breast implant illness symptoms.Severe gut pains, bone pains, swelling in hands, stiffness in legs.

• Brand Name: MENTOR SALINE TEXTURED BREAST IMPLANT
• Common Device Name: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6976765
• Report Number: MW5072945
• Device Sequence Number: 1546683
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2012
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 10/24/2017
• 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?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CASTOR OIL PACKS; MAGNESIUM BATHS; OTC MEDS: PROBIOTICS; RX MEDS: NONE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 29