Other, other text: h6: event problem and evaluation codes: updates not required.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr (device history review) was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available., corrected data: e4: correction: customer reported to fda: no information.
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