• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MENTOR SMOOTH SALINE BREAST IMPLANTS Back to Search Results
Event Date 11/24/1997
Event Type  Injury  
Event Description

This was the month and year i started having heart palpitations, inability to exercise, chronic fatigue, numbness, neck and back pain, frequent fevers, anxiety, lightheadedness, profound muscle weakness, couldn't recover from anything, feeling like i was literally going to die. Extreme endocrine (blood sugar fluctuations). Inability to sweat. Heat and cold intolerance. Rashes and sensitivities to any lotions, perfumes.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSMOOTH SALINE BREAST IMPLANTS
Type of DeviceSMOOTH SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6669668
Report NumberMW5070655
Device Sequence Number2
Product CodeFMW
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 06/24/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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: 06/24/2017 Patient Sequence Number: 1
-
-