HUFRIEDYGROUP
Received Oct 22, 2025 · Event occurred May 25, 2025
Report 3003933619-2025-70000 · MDR key 23355416
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR · Female
- Air Embolism
- Swelling/ Edema
- Air Embolism
- Swelling/ Edema
Narrative
Description of Event or Problem
A 80+ YEAR OLD PATIENT GOT AN AIR EMBOLISM DURING USE OF THE PWR PAIR.
Description of Event or Problem
ON (B)(6) 2025, WE WERE INFORMED BY OUR DISTRIBUTOR HU-FRIEDY GROUP THAT A PATIENT OF ONE OF THEIR CUSTOMERS EXPERIENCED AN ADVERSE EVENT DURING A TREATMENT WITH THE DEVICE OBJECT OF THE PRESENT REPORT. FROM A FIRST NOTICE, THE PATIENT CONDITION REPORTED BY THE DENTIST WAS AIR EMBOLISM THAT OCCURRED AFTER SCALING TREATMENT FOLLOWED BY ABOUT 1 SECOND OF PERIODONTAL AIR POLISHING. THE PATIENT WAS SENT BY THE DENTIST TO THE HOSPITAL AFTER HE NOTICED A SWELLING OF THE LEFT SIDE OF FACE, EYE, AND NECK.
Additional Manufacturer Narrative
ANALYSIS OF PRODUCTION RECORDS NO ANOMALIES OR NON-CONFORMITIES EMERGED FROM THE REVIEW OF PRODUCT RELEASE CONTROL DATA. TREND ANALYSIS NO HISTORICAL RECORDS AVAILABLE OF SIMILAR EVENTS FOR THIS OR SIMILAR PRODUCT. CLINICAL EVALUATION & CONCLUSION DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE PATIENT DECLINED TO PROVIDE FURTHER DIAGNOSTIC DETAILS REGARDING THE SUSPECTED AIR EMBOLISM. THE ONLY AVAILABLE CLINICAL INFORMATION INCLUDES REPORTED SWELLING ON THE LEFT SIDE OF THE FACE, EYE, AND NECK. DUE TO THE LACK OF CONFIRMED MEDICAL DIAGNOSIS AND THE ABSENCE OF INSTRUMENTAL EVIDENCE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE NATURE OF THE ADVERSE EVENT. FURTHERMORE, BASED ON THE TECHNICAL EVALUATION AND THE AVAILABLE USAGE DATA, NO CAUSAL RELATIONSHIP CAN BE ESTABLISHED BETWEEN THE ADVERSE EVENT AND THE MEDICAL DEVICE OR ITS METHOD OF USE.