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

MAUDE Adverse Event Report: MENTOR MENTOR SALINE TEXTURED BREAST IMPLANT 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 MENTOR SALINE TEXTURED BREAST IMPLANT SALINE BREAST IMPLANTS Back to Search Results
Event Date 04/01/2007
Event Type  Injury  
Event Description

My child was born when i had breast implants and was diagnosed with sensory integration disorders. Pain, swallowing issues, skin issues, high calcium, low potassium, high copper, leg pains, breast implant illness symptoms. Severe gut pains, bone pains, swelling in hands, stiffness in legs.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMENTOR SALINE TEXTURED BREAST IMPLANT
Type of DeviceSALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6976765
Report NumberMW5072945
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/24/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/25/2017
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: 10/25/2017 Patient Sequence Number: 1
Treatment
CASTOR OIL PACKS
MAGNESIUM BATHS
OTC MEDS: PROBIOTICS
RX MEDS: NONE.
-
-