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

Model Number 350-2225

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

Patient Problems Edema (1820); Urticaria (2278); Reaction (2414)

Event Type  Injury  

Event 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
• Type of Device: SM ROUND MOD PLUS PROFILE SALINE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6363917
• MDR Text Key: 68658272
• Report Number: MW5068156
• Device Sequence Number: 1
• 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: 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
• Device Operator: No Information
• Device Model Number: 350-2225
• Device Lot Number: 5684289
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: EPI-PEN; MAGNESIUM OCCASIONALLY. ; OTC MEDS: VITAMIN D3 OCCASIONALLY; POTASSIUM; PREDNISONE OCCASIONALLY.; PROBIOTICS OCCASIONALLY.; RX MEDS: FUROSEMIDE; SPIRONOLACTONE
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Weight: 65