H.3., h.6.: investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Additional information provided in h.3., h.6., and h.10.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.There was no service requested by the customer (in response to the reported event).Therefore, an onsite assessment of the product was not performed.Based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
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