The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6) 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 8030647-2020-00017 for the second report.A case report was received which indicated a patient experienced a 3cm erythematous skin lesion on his right gluteal region consistent with a cutaneous burn two days following a cooled rf [radiofrequency] procedure to the si [sacroiliac] joint (right-sided l5-s3).No treatment mentioned.At three-month follow-up, burn had improved more than 50% and the patient was referred to dermatology for further evaluation.Patient received 100% pain relief for original issue being treated.
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