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
Dec 16, 2020
TRAVERSE CITY â Older women in the greater Traverse City, Kalamazoo and Grand Rapids area may have been victimized in multiple ways if treated for incontinence by a particular traveling medical outfit.
Officials said four people have now pleaded guilty to crimes as an outcome of a federal investigation into both the misuse of medical devices and health care fraud, often during medical visits with senior women at long-term care and skilled nursing facilities. Three have already been sentenced.
Authorities said an investigation revealed a medical device manufacturer employee, as well as a doctor and his nurse practitioner spouse, conspired to wrongly use medical equipment during a therapy practice called pelvic muscle rehabilitation. All three have now pleaded guilty in U.S. District Court for Michiganâs Western District to charges stemming from the scheme.