Additional information: age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Exact date not provided, best estimate (b)(6) 2020.Lot#: unknown, information not provided.Unique identifier: udi# is unknown as the lot# was not provided.Expiration date: unknown, as lot number was not provided.(b)(6).Device manufactured date: unknown, as lot number was not provided.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified.Manufacturing record review: a review of the records could not be performed as the product lot number was not provided.Conclusion: based on the investigation, no product deficiency could be determined.It is unknown if the product was used per the directions for use.Attempt(s) have been made to obtain missing information; however, to date, no response has been received.All.
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