Other, other text: h6: event problem and evaluation codes: updated.H10: no lot number was provided; therefore, device history record review could not be completed.Device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.No lot number was provided; therefore, dhr (device history review) could not be performed.
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