Pr (b)(4) initial mdr.A follow up will be submitted if additional information becomes available.Patient problem code: 2414, device problem code: 2993.Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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