A4=unknown.
Mfr completed section f.
F13: manufacturer did not receive a medwatch report.
H6: product was not returned to manufacturer for evaluation.
"the medical device reporting regulations (21 c.
F.
R.
Part 803, et seq) require chiron vision corp and others to report to the fda certain device and product related information.
The submission of such information is without prejudice and does not constitute an acknowledgment of the validity or relevance of such information or an admission or indication that the subject device or product malfunctioned or was causally connected to any reported death or injury.
".
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