Personal Injury Law

FDA: Device Maker Failed to Report Death of Patient

By Edward Bills

A Texas-based medical device maker failed to report the death of a 4-year-old patient fitted with a one-of-its-kind pediatric heart pump, according to a warning letter by the U.S. Food and Drug Administration. In the letter, the agency said MicroMed Cardiovascular should have reported that the DeBakey VAD Child Device may have caused or contributed to the death of the child. MicroMed maintains that the device worked properly and played no role in the patient?s death.

Full post as published by Bodily Injury Blog on March 15, 2010 (boomark / email).