MIDMARK
Received Feb 14, 2025 · Event occurred Jan 22, 2025
Report 1523530-2025-00001 · MDR key 21389193
Device
Product problems
- Device Fell
- Device Fell
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
UPON THE INITIAL REPORT OF THE DESCRIBED INSTANCE WITHIN INITIAL REPORT, 1523530-2025-00001 ON BEHALF OF MIDMARK CORPORATION, MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO OBTAIN FURTHER INFORMATION OF BOTH THE INJURY AND THE PRODUCT MALFUNCTION. IN THE LAST CORRESPONDENCE FROM THE CUSTOMER, IT WAS STATED THAT AFTER A REVIEW CONDUCTED BY CUSTOMERS OFFICE, IT DOES NOT APPEAR THAT ANY MALFUNCTION OF THE LIGHT OCCURRED THAT LED TO THE STUDENT INJURY. NO FURTHER ACTION TO BE TAKEN IN THIS INSTANCE.
Description of Event or Problem
IT WAS REPORTED TO MIDMARK CORPORATION THAT ON OR AROUND (B)(6) 2025, A LED DENTAL LIGHT FELL AND HURT A STUDENT AT A DENTAL COLLEGE. THE STUDENT RECEIVED A PINCH FROM THE LIGHT. NO FURTHER DETAILS OF THE SEVERITY OF THE INJURY HAS BEEN MADE AT THE TIME OF THE INITIAL REPORT. DUE TO PREVIOUS REPORTING OF LIKE INSTANCES OF LED DENTAL LIGHTS FALLING, MIDMARK CORPORATION COMPLIED TO REPORT THIS INSTANCE.
Additional Manufacturer Narrative
MULTIPLE ATTEMPTS HAVE BEEN MADE AND DOCUMENTED TO OBTAIN FUTHER INFORMATION OF BOTH THE INJURY AND THE FALLING LIGHT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO US BY THE CUSTOMER. UPON FURTHER INFORMATION RECEIVED, MIDMARK CORPORATION WILL COMPLY WITH A FOLLOW UP REPORT AS APPLICABLE.
Description of Event or Problem
IT WAS REPORTED TO MIDMARK CORPORATION THAT ON OR AROUND (B)(6) 2025, A LED DENTAL LIGHT FELL AND HURT A STUDENT AT A DENTAL COLLEGE. THE STUDENT RECEIVED A PINCH FROM THE LIGHT. NO FURTHER DETAILS OF THE SEVERITY OF THE INJURY HAS BEEN MADE AT THE TIME OF THIS REPORT. DUE TO PREVIOUS REPORTING OF LIKE INSTANCES OF LED DENTAL LIGHTS FALLING, MIDMARK CORPORATION COMPLIED TO REPORT THIS INSTANCE.
Remedial action
- Replace