CYNOSURE CELLULAZE - SLT II
Received Feb 6, 2019 · Event occurred Apr 19, 2018
Report 1222993-2019-00003 · MDR key 8313178
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR
- Death
- Patient Problem/Medical Problem
- Death
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
IT WAS MADE AWARE THAT A PATIENT DEATH OCCURRED FOLLOWING A LASER TREATMENT ON THE THIGHS AREA. THIS CLAIM WAS MADE BY THE PATIENT'S BROTHER WHO INDICATED THAT THE DEATH WAS DUE TO BLEEDING. HOWEVER, THE CUSTOMER SITE STATED THE PATIENT'S LASER TREATMENT HAD PROCEEDED NORMALLY AND HER BLOOD PRESSURE WAS IN GOOD STANDING. THE CUSTOMER SITE STATED THAT THE PATIENT DID NOT SHOW UP FOR ANY FOLLOW UP CHECKUPS. PRIOR TO THE LASER TREATMENT, IT WAS DISCLOSED THAT THE PATIENT WAS CURRENTLY TAKING ANTIDEPRESSANT MEDICATIONS. PATIENT WAS ALSO GIVEN ALPRAZOLAM ORALLY FOR SEDATION AND LIDOCAINE/EPINEPHRINE FOR TUMESCENT ANESTHESIA AS PART OF THE PRE-TREATMENT ACTIVITIES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER SITE REGARDING THE PATIENT'S DEATH OR TREATMENT PROCEDURE. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATED AS INTENDED WITHIN SPECIFICATION. ONE OF THE EXPECTED SIDE EFFECTS FROM AN SLT II LASER PROCEDURE IS BLEEDING, BUT DUE TO LIMITED INFORMATION AVAILABLE, A RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND PROCEDURE COULD NOT BE DETERMINED FROM THIS INVESTIGATION. THIS IS A REPORTABLE EVENT DUE TO A PATIENT DEATH.
Description of Event or Problem
A PATIENT HAD DIED FOLLOWING A LASER PROCEDURE WITH THE SLT II DEVICE.