Procode: qhp without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2022-00295 through 3012447612-2022-00306.
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Corrections in a1 and b7.Additional information in a2: dob, a4, and h6: component, investigation type, findings, and conclusions.Device evaluation: the product was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to insufficient tension being applied to the cord as a result of unfamiliarity with the instrument.This event could also be the result of patient anatomy or other patient specific factors.Dhr review: the lot numbers were not provided, so the dhrs were unable to be reviewed.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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