Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter zip code : unknown.Investigation summary : exec summary - no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Capa/sa - based on the investigation, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.Dhr review - a review of the device history record was completed for batch# 0321244.All inspections and challenges were performed per the applicable operations qc specifications.
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