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. GEL-FILLED MMRY IMPLANT UNKNOWN MANUFACTU MAM IMP GEL-FILLED   back to search results
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Pt alleges one of implants leaking.

 
Manufacturer Narrative

03/24/2000-sent first attempt letter requesting additional info. 04/07/2000-sent second attempt letter requesting additional info. Dates are estimated. Only the year of implantation is known.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameGEL-FILLED MMRY IMPLANT UNKNOWN MANUFACTU
Type of DeviceMAM IMP GEL-FILLED
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DOW CORNING CORP.
1635 n. gleaner road
hemlock MI 48626
Manufacturer (Section D)
DOW CORNING CORP.
1635 n. gleaner road
hemlock MI 48626
Manufacturer Contact
jan classens
3901 s. saginaw rd
midland , MI 48640
(517) 496 -5140
Device Event Key265801
MDR Report Key274613
Event Key257458
Report Number1816403-2000-00027
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial,Followup
Report Date 03/20/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NOT APPLICABLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/20/2000
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

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