During retrospective review on 20mar2017, it was identified that the mdr was incorrectly reported submitted under the incorrect manufacturing site.All information initially submitted under 8030647-2016-00012 is included in this mdr 3006646024 -2017-00008.Corrected manufacturing site information.Corrected typographical error in type of reportable event.(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 04apr2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).Device not returned.
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