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

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
• Report Number: MW5072945
• Device Sequence Number: 1
• Product Code: FWM
• 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

• Date FDA Received: 10/25/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Was Device Available For Evaluation?: No
• 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: 10/25/2017 Patient Sequence Number: 1

Treatment

CASTOR OIL PACKS

MAGNESIUM BATHS

OTC MEDS: PROBIOTICS

RX MEDS: NONE.