SAPPHIRE
Received Dec 2, 2015 · Event occurred Nov 2, 2015
Report 3006981798-2015-00004 · MDR key 5270378
Device
Generic name
Sapphire
Manufacturer
Riverpoint MedicalModel number
MLS01Catalog number
MLS01
Lot number
130627-00007300
Product problems
- Overheating of Device
Patient
Not reported
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE USE CONDITIONS WERE REPRODUCED BY DISTRIBUTOR AND THE UNIT DID NOT BECOME HOT, THE REPORTED ISSUE COULD NOT BE RECREATED. DEVICE HISTORY FILES FOR THIS PRODUCT CODE WERE REVIEWED AND NO ISSUES IDENTIFIED. NO CONCLUSION CAN BE DRAWN AT THIS TIME, THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR ADDITIONAL TESTING AND A SUPPLEMENTAL 3500A WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem
THE UNIT BECAME HOT AND BURNED THE USERS RIGHT UPPER EAR. THE BURN WAS TREATED AND THERE WAS NO OTHER REPORTED ISSUES AT THIS TIME.