The device, used in treatment, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A dhr review could not be performed because the lot number was not provided.A complaint review was performed with the part number and showed no other complaints of patient burn.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.The instructions for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Per ifu precautions: ¿the metal tip of the light cable may be hot when it is removed from the light source.To avoid injury during removal, grasp the cable only by the source-end versitip adaptor used to secure the cable to the light source.Failure to observe these warnings may result in burns to skin, clothing, or other material inadvertently placed in front of the light post or cable.¿ should the device or additional information be received, the complaint can be reopened and reevaluated.
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