• 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 ROUND HIGH GEL BREAST IMPLANT

  • 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 ROUND HIGH GEL BREAST IMPLANT Back to Search Results
Catalog Number 350-4504C
Event Date 03/01/2011
Event Type  Injury  
Event Description

Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. Worsened over a period of 5-7 years post implant. Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. Epidurals and physical therapy for years. Only improvement with prednisone. No improvement with nsaids (multiple tried). Developed anxiety and uncontrolled vaso-vagal responses.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSMOOTH ROUND HIGH GEL BREAST IMPLANT
Type of DeviceSMOOTH ROUND HIGH GEL BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6452817
Report NumberMW5068832
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/30/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received03/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number350-4504C
Device LOT Number5778410
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: 03/30/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: VITAMIN D
PROBIOTIC
RX MEDS: NONE.
-
-