MAUDE Adverse Event Report: DOW CORNING / MENTOR SILICONE BREAST IMPLANT

Model Number STYLE 235CC

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 12/15/2016

Event Type  Injury  

Event Description

Believe my silicone breast implant was ruptured after a mammogram.

• Brand Name: SILICONE BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): DOW CORNING / MENTOR
• MDR Report Key: 6834520
• MDR Text Key: 84344392
• Report Number: MW5071884
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: STYLE 235CC
• Device Catalogue Number: 993
• Device Lot Number: HH046098
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Weight: 82