After analyzing the documentation, we believe that the reported event cannot be considered a serious injury.The patient has been experiencing a temporary skin rash months before the complaint submission and now he doesn't have reported any consequences.Therefore, the following definition is not applicable to this case: (w) serious injury means an injury or illness that: is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.The dhr doesn't show any irregularities during the production phase and shows correct and regular values in the laser emission, functional and electrical safety tests.The service activities performed on the device after its sale didn't show problems related to the emission values of the device.The laser emission measurements taken after the event don't show any over-emission anomalies in the system.The scheduled post-market monitoring of the treatments performed with same or similar devices doesn't show any undesirable side effects similar to the ones described in this case, neither with the same treating parameters nor with different treating parameters.Moreover, the scientific literature doesn't show any contraindications in using diode laser emissions with titanium plaques.According to our analysis, there are no actions to be taken on the device or on the market.However, we will maintain a high level of market surveillance to monitor similar events.If the fda doesn't have any further notes regarding this case, we consider the case closed.
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