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

DOW CORNING CORP HEALTHCARE BREAST IMPLANT PROSTHESES, MAMMARY   back to search results
Model Number 235CC
Event Description

Explant, defective product.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameBREAST IMPLANT
Type of DevicePROSTHESES, MAMMARY
Baseline Brand NameSILASTIC MMRY RND NFP 235CC
Baseline Generic NameMAM IMP GEL-FILLED
Baseline Catalogue Number974
Baseline Model Number235CC
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DOW CORNING CORP HEALTHCARE
635 n gleaner rd
hemlock MI 48626
Device Event Key497825
MDR Report Key508878
Event Key482730
Report NumberMW1030960
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Report Date 01/19/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number235CC
Was Device Available For Evaluation? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Database last updated on January 06, 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