The patient was reported to be in their (b)(6).Initial reporter phone no.: (b)(6).Initial reporter address: (b)(6).The device was not received for evaluation, however, a picture and video were provided for investigation.The inspection of the provided video and the provided photo showed the product during treatment.Visual inspection observed fluid dripping.The reported condition was verified.The cause could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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