MAUDE Adverse Event Report: DOW CORNING/ MENTOR WORLDWIDE LLC DOW SILICONE BREAST IMPLANT; PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE GEL-FILLED

Model Number ?

Device Problem Degraded (1153)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/27/2018

Event Type  Injury  

Event Description

My 40 years old silicone implants by dow need to be removed, evidence is degrading.Dr said they need to come out.I dont have money to do this.Any relief.

• Brand Name: DOW SILICONE BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE GEL-FILLED
• Manufacturer (Section D): DOW CORNING/ MENTOR WORLDWIDE LLC
• MDR Report Key: 8464627
• MDR Text Key: 140504043
• Report Number: MW5085325
• Device Sequence Number: 0
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ?
• Device Catalogue Number: ??
• Device Lot Number: ?
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 85