MAUDE Adverse Event Report: MENTOR SM ROUND MOD PLUS PROFILE SALINE

Model Number	350-2225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Urticaria (2278); Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
Breast implants thought to be cause of health problems.After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives.Never had problems before implants.

• Brand Name: SM ROUND MOD PLUS PROFILE SALINE
• Common Device Name: SM ROUND MOD PLUS PROFILE SALINE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6363917
• Report Number: MW5068156
• Device Sequence Number: 761839
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 02/25/2017
• 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
• Device Model Number: 350-2225
• Device Lot Number: 5684289
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EPI-PEN; MAGNESIUM OCCASIONALLY. ; OTC MEDS: VITAMIN D3 OCCASIONALLY; POTASSIUM; PREDNISONE OCCASIONALLY.; PROBIOTICS OCCASIONALLY.; RX MEDS: FUROSEMIDE; SPIRONOLACTONE
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 39 YR
• Patient Weight: 65