Thermage-modifications to our ThermaTips

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

Thermage-modifications to our ThermaTips

PostPosted by hopeful19 » Mon Jan 23, 2012 3:36 am

This excerpt taken from the THRM 10-Q filed Nov 10, 2008.

After-market modifications to our ThermaTips by third parties and the development of counterfeit treatment tips could reduce ThermaTip sales, expose us to product liability litigation and dilute our brand quality.
Third parties have introduced adulterated after-market modifications to our ThermaTips which have enabled re-use of our ThermaTips in multiple procedures. Because our ThermaTips are designed to withstand a finite number of firings, modifications intended to increase the number of firings could result in patient injuries caused by the use of worn-out or damaged ThermaTips. In addition, third parties may seek to develop counterfeit treatment tips that are compatible with our ThermaCool system and available to practitioners at lower prices than our own. If security features incorporated into the design of our ThermaCool system are unable to prevent after-market modifications to our ThermaTips or the introduction of counterfeit treatment tips, we could be subject to reduced ThermaTip sales, product liability lawsuits resulting from the use of damaged or defective goods and damage to our reputation for providing a quality product.
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
-Einstein
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