MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Arthralgia (2355); Cognitive Changes (2551)

Event Date 04/01/2009

Event Type  Injury  

Event Description

Insidious health problems increasing in severity over a four year period after breast implant procedure to include; debilitating fatigue, chronic and debilitating joint pain, and cognitive dysfunction.

• Brand Name: SALINE BREAST IMPLANT
• Type of Device: SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6566553
• MDR Text Key: 75242397
• Report Number: MW5069759
• 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: 05/11/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 05/11/2017 Patient Sequence Number: 1

Treatment

COLOSTRUM; MAGNESIUM; MONOLAURIN; OTC MEDS: VITAMIN D; PROBIOTICS; RX MEDS: FLORINEF; TRAMADOL; VITAMIN C