Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1133341.Medical device expiration date: 2024-05-31.Device manufacture date: 2021-05-13.Medical device lot #: 1133339.Medical device expiration date: 2024-05-31.Device manufacture date: 2021-05-13.The customer's address is unknown.(b)(6), usa has been used as a placeholder based on the reported phone area code.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306499 and lot numbers 1133339 and 1133341.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.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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