http://www.fda.gov/MedicalDevices/Devic ... 359130.htm
The fox is still guarding the hen house..
2.12 What are my responsibilities for investigating a voluntary report when the source of the report is unknown to me?
In this case, you must evaluate the complaint to determine whether it represents an MDR reportable event [21 CFR 820.198(a) and 803.18]. Your evaluation must include information in your possession or information you can obtain by contacting a user facility, importer or other initial reporter related to the adverse event [21 CFR 803.50]. Such information would include what is provided in the voluntary report, along with your knowledge of the device [21 CFR 803.18; see also 21 CFR 803.17, 803.50(b), and 820.198]. Your decision about whether or not the event is an MDR reportable event should be based on the findings of your evaluation.