MEDLED
Received Sep 28, 2022 · Event occurred Aug 31, 2022
Report 3006981798-2022-00033 · MDR key 15499564
Device
Product problems
- Overheating of Device
- Overheating of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR EVALUATION AT THIS TIME. THE REPORT HAS NOT BEEN SUBSTANTIATED AND A CAUSE FOR THE EVENT HAS NOT BEEN ESTABLISHED. THE INVESTIGATION IS ONGOING. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY THE FDA.
Description of Event or Problem
ACCORDING TO THE REPORTER, "IT WAS REPORTED BATTERIES OVERHEATED AND BROKE DURING USE. HOSPITAL STATES TWO BATTERIES BEING USED IN SAPPHIRE HEADLIGHT OVERHEATED, CAUSING SWELLING THAT CRACKED HOUSING OF BATTERIES WHILE IN USE. HEADLIGHT WAS IN USE AT TIME OF EVENT, AND WAS QUICKLY REMOVED FROM USE."