The patient code was selected to be no code available as an appropriate code for the alleged outpouching does not exist.The lot number of the ck-1 in use during this treatment was not provided.The serial numbers of two cellfina motor modules were provided.The physician did not provide information on which of the motor modules were used during the treatment.An evaluation of the original dhr found that these two motor modules have no deviations and passed all tests.As the physician did not allege any malfunctions and since the motor modules do not have direct contact with the patient, these devices were not requested back for evaluation.The outpouching was reported to occur in an area where cellfina is not recommended to be used.The cellfina training recommends avoiding non-cellulite areas including anatomical junction points.The report contains no allegation of a malfunction and one cannot be confirmed.There is not enough information to confirm whether a device caused or contributed to the event.The physician was unable to judge whether the outpouching was permanent; however, the cellfina trainer alleged that the outcome will likely be permanent.Additional information was not provided despite multiple attempts.It should be noted, though the original date of awareness for the complaint is (b)(6) 2019, additional information was obtained on 1-april-2019 which led to the decision to file this report.Should additional information regarding this event become available, a supplemental medwatch form will be filed.
|