Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: as no physical samples, material and/or lot numbers were provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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