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Clini cal Director for The Prometheus Group Pleads Guilty for Role in Causing the Reuse of Single-User Rectal Pressure Sensors on Multiple Patients GRAND RAPIDS, MICHIGAN U.S. Attorney Andrew B. Birge announced today that Denise D’Andrea pleaded guilty to one count of causing the adulteration of a medical device.  In the criminal information, the government alleged that Ms. D’Andrea, the Director of Clinical Services at The Prometheus Group (“Prometheus”), a device manufacturer headquartered in Dover, New Hampshire, trained medical practitioners in the Western District of Michigan to reuse a single-user rectal pressure sensor on multiple patients by covering it with a surgical glove between uses.  The rectal pressure sensor is a component part of Prometheus’s Pathway CTS 2000 Pelvic Floor Training System used in a form of therapy known as pelvic muscle rehabilitation.  FDA cleared this system for introduction into the market in 2000, but restricted use of the rectal

New hampshireUnited statesGrand rapidsSusan wrightDenise dandreaRosss goldsteinLyndam burdelikRaymonde beckeringJanett neffRoger beyerAndrewb birgeDepartment of justiceUs department of healthHuman servicesOffice of inspectorPrometheus group