MAUDE Adverse Event Report: IDEAL IMPLANT INCORPORATED IDEAL BREAST IMPLANTS; SALINE BREAST IMPLANTS

Health Effect - Clinical Codes	Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Nausea (1970); Chills (2191)
Date of Event	02/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
I had breast augmentation from dr (b)(6) , (b)(6) 2017.(b)(6) is when i started getting symptoms.Fever, body chills, nausea, headache, high blood pressure.I have had extensive blood work.Ct scans, mris, and bone marrow.I have been seen by an internist, infectious disease doctor, and a rheumatologist.

• Brand Name: IDEAL BREAST IMPLANTS
• Common Device Name: SALINE BREAST IMPLANTS
• Manufacturer (Section D): IDEAL IMPLANT INCORPORATED
• MDR Report Key: 6669587
• Report Number: MW5070647
• Device Sequence Number: 41325
• Product Code: FWM
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/25/2017
• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Weight: 63