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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Nausea (1970); Chills (2191)

Event Date 02/25/2017

Event Type  Injury  

Event 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
• Type of Device: SALINE BREAST IMPLANTS
• Manufacturer (Section D): IDEAL IMPLANT INCORPORATED
• MDR Report Key: 6669587
• MDR Text Key: 78572596
• Report Number: MW5070647
• Device Sequence Number: 2
• Product Code: FWM
• 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: 06/25/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 63