A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Further information and logfiles are requested, but not received.The sample was not returned to the manufacturer for evaluation.A sample was not received at the production site and insufficient information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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