The serial number was not provided by the customer, therefore the device history records could not be reviewed, however, inspection procedures require any oscor product pass all in-process and qa final inspection before shipping to the customer.The device was used in treatment and not returned for analysis.There was no performance related failure reported by the user.No further investigation is required.No further follow-up is required.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.
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Correction to h10: corrected that the lot number was not provided instead of the serial number, as this product does not have serial numbers.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.
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