Company: James Howe M.D. – University of Vermont College of Medicine
Product: Investigational device
Date: 1/16/04
The x-rays and radiology report for patient [redacted] 24-month visit in 2002 were not included in the subject’s file. The patient’s Radiographic Evaluation form you signed on September 27, 2002, shortly after [redacted] 24-month visit was scheduled to take place, indicated that you evaluated the x-rays for this patient’s 24-month visit. However, there were no visits for [redacted] in 2002 indicated on the hospital’s computer printout. According to hospital records, the date of the subject’s last visit for x-rays was September 19, 2001 and the printout indicated that the Status of that x-ray report was a “Final Report.” Accordingly, it is unclear when those missing x-rays could have been taken.
Issuer: Center for Devices and Radiological Health (CDRH)