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

Device Problem Insufficient Information (3190)

Patient Problems Congenital Defect/Deformity (1782); Pain (1994); Swelling (2091); Electrolyte Imbalance (2196)

Event Date 04/01/2007

Event Type  Injury  

Event 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
• Type of Device: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6976765
• MDR Text Key: 90226557
• Report Number: MW5072945
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CASTOR OIL PACKS; MAGNESIUM BATHS; OTC MEDS: PROBIOTICS; RX MEDS: NONE.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 29