MAUDE Adverse Event Report: MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS

Model Number 350-1460

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

Patient Problem Cellulitis (1768)

Event Date 06/27/2016

Event Type  Injury  

Event Description

I developed reoccurring breast cellulitis due to 10 year old saline breast implants.

• Brand Name: SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6260478
• MDR Text Key: 65313781
• Report Number: MW5067289
• 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: 01/15/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-1460
• Device Lot Number: 5730849
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 86