FDA MAUDE MW4002086 files re: free mercury/dental amalgams

Beryl Lipton filed this request with the Food and Drug Administration of the United States of America.
Tracking # 2016-50
Status
Completed

Communications

From: Beryl Lipton

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

All files, reports, follow up materials, references to other agencies, and any other related materials regarding MAUDE Event Report Number MW4002086, received by the Food and Drug Administration on November 18, 1997 regarding the Kerr Corporation. It stated:

"IN A ROUTINE PHONE CONVERSATION RPTR WAS ALERTED TO THE POSSIBILITY THAT THERE MAY BE FREE MERCURY IN AMALGAM TRITURATORS. SOME OF TRITURATORS WERE FOUND TO HAVE FREE MERCURY PRESENT ON THE MIXING PLATFORM. FURTHER CONVERSATION REVEALED THAT TRITURATORS WHERE TYTIN SPHERICAL ALLOY (KEN CORP) IS MIXED ARE AFFECTED. ACCORDING TO RPTR OTHER ALLOYS USED IN CLINIC DID NOT SEEM TO CONTAMINATE THE TRITURATORS. THE TYTIN SPHERICAL ALLOY CAPSULES WITH CERTAIN LOT NUMBERS MAY BE DEFECTIVE. SEVERAL OTHER MILITARY CLINICS HAVE BEEN SIMILARLY AFFECTED. BECAUSE FREE ELEMENTAL MERCURY IS A KNOWN HLTH HAZARD. RPTR IS INITIATING THIS MATERIAL COMPLAINT."

Please include all available datasets, spreadsheets, and other materials regarding investigation of this report, including all available segregable data. Please include all available lists of affected military clinics and other locations.

This request is being made as part of a journalistic investigation into mercury amalgams. The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Beryl C.D. Lipton

From: Food and Drug Administration

An interim response, stating the request is being processed.

From: Food and Drug Administration

A copy of documents responsive to the request.

From: Food and Drug Administration

A cover letter granting the request and outlining any exempted materials, if any.

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