U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During treatments, using the prostatron units, the devices' temperature sensing system may change the rectal temperature reading by up to 2 degrees celsius and may briefly delay updates to the rectal temperature reading.
조치
A letter about the problem, actions to take to avoid the problem, and the proposed software correction was sent to consignees on December 10, 2003. A software upgrade will be performed on all units in March 2004.
The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.
제품 설명
Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from a series of temperature sensors.