FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

BAXTER V. MUELLER MAMMARY PROSTHESIS   back to search results
Model Number BILUMEN-SILICONE/SALINE
Patient Outcome  Hospitalization; Life Threatening Required Intervention Disability
Event Description

Saline breast implants implanted 1978 ruptured within 6 months of implant. These were black with fungus. Silicone/saline implants replaced these. These encapsulized & had to be surgically removed. These were replaced with bilumen silicone gel/saline. She immediately became seriously ill, & drs could not find the problem. Explanted 3/95. She has lupus & multiple medical problems. 100% disabled-awarded 100% disability under social security-on medicaid & social services.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameMAMMARY PROSTHESIS
Type of DeviceMAMMARY PROSTHESIS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAXTER V. MUELLER
mcgaw park IL 60085
Device Event Key27087
MDR Report Key26413
Event Key24628
Report NumberMW1007170
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Report Date 08/16/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/1995
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberBILUMEN-SILICONE/SALINE
Device Catalogue Number360-7275
OTHER Device ID NumberIMPLANTS
Was Device Available For Evaluation? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH