Device was used for treatment, not diagnosis.Date of birth and weight were not provided for reporting.(b)(4).Device history records review was completed.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was returned for investigation for an unrelated issue. upon visual evaluation of the returned device, it was noted that the metal cutter was completely separated from the container. it is unknown how the product was being used at the time and the consumer did not report the metal cutter separation. at this time, no conclusion is able to be drawn about the cause of the metal cutter separation as no additional information is available regarding the use of the device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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