Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(6).Results: a sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Udi# (b)(4).
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