The actual glove involved in the complaint 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.Images provided of the skin graft show that the injury appears to be above the skin area the glove normally covers.Additionally, the glove is not intended to provide a thermal barrier.All information reasonably known as of 02oct2017 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 halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
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