California Importer and Manufacturer Cited for Late, Incomplete MDRs
Nihon Kohden’s Irvine, California facility was written up by the FDA in a Form 483 for medical device reports (MDRs) that were late and lacked information.
In an inspection, the agency reviewed 13 MDRs for SpO2 oxyhemoglobin saturation probes. It determined that eight reports were submitted to the agency more than 30 days after the firm learned that the devices may have been involved in injuries to neonates and infants, including burns and sores.
In addition, at least 13 MDRs lacked “reasonably known” information, including patient age, date of birth, weight, ethnicity, race and relevant medical history, the agency said.