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FDA Warns Covidien plc (COV) Over Surgical-staple Deaths



6/28/2012 8:10:46 AM

Boston Business Journal by Julie M. Donnelly, Reporter

The U.S. Food and Drug Administration (FDA) has sent a warning letter to Covidien plc (NYSE: COV) saying the company has failed to address serious concerns about its Duet Tissue Reinforcement System (TRS) Reload, a medical device which includes surgical staples.

Covidien recalled its Duet surgical staples devices in January, after the company received reports of 13 serious injuries and three deaths. The FDA says that among other violations, Covidien, with U.S. headquarters in Mansfield, Mass., failed to document investigations into the deaths and injuries, and also failed to put into place a corrective action plan in a timely fashion, despite first receiving complaints in 2009.

The FDA says it inspected a Covidien plant in North Haven, Conn. between January 13, 2012, through February 09, 2012, and found a number of violations. The FDA called inadequate the company’s responses to a previous warning letter detailing the violations.

The agency says Covidien failed to initiate a corrective and preventative action (CAPA) plan for the device in a timely fashion. The letter reads in part:

“Despite receiving numerous complaints, adverse event, and serious adverse event information since May of 2009 regarding use of the DUET TRS, a CAPA investigation was not initiated until January 19, 2012 and after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events.”

“Despite receiving numerous complaints, adverse event, and serious adverse event information since May of 2009 regarding use of the DUET TRS, a CAPA investigation was not initiated until January 19, 2012 and after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events.”

The FDA said Covidien’s response, that the company believed that a corrective plan was not required in accordance with the firm’s standard operating procedures, was not adequate. According to the letter, Covidien "did not provide a description or evidence of implementation of a correction or corrective action, including retrospective review of complaints to ensure that documented corrective actions were implemented, for the complaints received for abdominal indications of use for similar patient injuries/deaths."

The company was warned that “failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice,” including seizure, injunction of civil money penalties.

"Covidien is working to address the FDA’s concerns related to our North Haven, Connecticut facility and the DUET TRS product manufactured there," Covidien spokesman Bruce Farmer wrote in an email. "We will respond to the FDA within the specified timeframe and address these issues in a timely manner."




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