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Medical Device Manufacturer's Director of Clinical Services Pleads Guilty to Causing the Adulteration of Rectal Pressure Sensors


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 th ....

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Fourth person convicted in scheme to misuse medical equipment, commit health care fraud


Dec 16, 2020
TRAVERSE CITY — 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 Michigan’s Western District to charges stemming from the scheme. ....

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