(b)(4).Date of event: unknown, assumed first day of month that complaint was reported.Batch # unk.Additional information was requested and the following was obtained: "do we know if the previous complaints referred to in the event description were previously reported, or do the three complaint files created with this event description (b)(4) cover these? the three complaints (b)(4) created cover the previous complaints mentioned in the description." an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.
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