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FDA warns Vasca over faulty reporting of deaths, injuries caused by device.

Vasca, Inc., Tewksbury, MA has received at least 129 complaints involving death or injuries since it began marketing a kidney dialysis device in 1998, according to the US Food and Drug Administration (FDA). In a letter to the company in November, the FDA accused the company of reporting some of the incidents late and not investigating the deaths properly, according to a report in The Patriot Ledger.

The device, called LifeSite, is a shunt that in implanted under the skin and connects with the dialysis machine.

The FDA noted in the letter that in 20 cases investigators "found information to reasonably suggest" the device "may have caused or contributed to a death or injury" or that the device malfunctioned in a way that could hurt a patient if the problem recurred.

Vasca President Thomas Glover told the press the company has responded to the letter and is currently in discussions with the FDA. Glover blamed a misunderstanding of the FDA's regulations for the paperwork problem.

The FDA letter, which is posted on its web site (www.fda.gov) warns that regulatory action will be taken if the company doesn't address the problems.

According to Glover, about 3,000 patients in the US have used LifeSite since its approval in 2000. The device was approved in Canada in 1999 and Europe in 1998.
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Comment:FDA warns Vasca over faulty reporting of deaths, injuries caused by device.
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Jan 12, 2002
Words:222
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