InjuryKGL
ULTRALITE PHOTOTHERAPY UNIT
Received Dec 10, 2012 · Event occurred Oct 8, 2012
Report 1045025-2012-00001 · MDR key 2869659
Device
Product problems
- Insufficient Device Problem Information
Patient
64 YR
Narrative
Description of Event or Problem
UEI BECAME AWARE OF AN EVENT THAT OCCURRED ON (B)(6) 2012, ON (B)(4) 2012 BY A REPORT FROM MEDWATCH. THE REPORT STATES A PT WAS UNDERGOING A PHOTOTHERAPY AND FOUR DAYS AFTER THE TREATMENT THE PT HAD BLISTERING ON HIS THIGHS AND NECK. IT WAS DECIDED A MDR SHOULD BE FILED.
Additional Manufacturer Narrative
UEI CONTACTED (B)(4). (B)(6) SPOKE TO (B)(6) AND FOUND THE UNIT WAS REFERENCED AND CALIBRATED CORRECTLY THAT IT WAS A STAFF ERROR. OUR CONVERSATION CONFIRMED THAT THE MACHINE WAS OPERATING PROPERLY AND NO OTHER INCIDENT HAD TAKEN PLACE.