MPHI
Received Oct 26, 2017 · Event occurred Sep 15, 2017
Report 3004724437-2017-00001 · MDR key 6979702
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
46 YR
- Itching Sensation
- Burn, Thermal
- Itching Sensation
- Burn, Thermal
Narrative
Additional Manufacturer Narrative
ADEQUATE INFORMATION TO COMPLETE THE INVESTIGATION ON THE CASE IS NOT YET AVAILABLE. THE INVESTIGATION ACTIVITIES CONTINUE AND WILL FOLLOW FOLLOW-UP.
Description of Event or Problem
THE PATIENT REPORTED A RED BURN, ITCHY LESION ON RIGHT POSTERIOR SHOULDER A FEW HOURS AFTER THE FIRST THERAPY SESSION.
Additional Manufacturer Narrative
AFTER ANALYZING THE DOCUMENTATION, WE BELIEVE THAT THE REPORTED EVENT CANNOT BE CONSIDERED A SERIOUS INJURY. THE PATIENT HAS A TRIVIAL (SUPERFICIAL AND TEMPORARY) SKIN DAMAGE. THEREFORE, THE FOLLOWING DEFINITION IS NOT APPLICABLE TO THIS CASE: 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. NO SERVICE ACTIVITIES HAVE BEEN PERFORMED ON THE DEVICE AFTER THE SALE OF THE DEVICE. THE LASER EMISSION MEASUREMENTS TAKEN AFTER THE EVENT DON'T SHOW ANY 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. 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.
Description of Event or Problem
THE PATIENT REPORTED A RED BURN, ITCHY LESION ON RIGHT POSTERIOR SHOULDER A FEW HOURS AFTER THE FIRST THERAPY SESSION.