UNKNOWN
Received Jan 17, 2024
Report 1416605-2024-00001 · MDR key 18528138
Device
Generic name
Unknown
Manufacturer
Hu-friedy Mfg. Co. LlcProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
THE SHOWCASE INSTRUMENTS PRESENT WITHIN THE CASSETTE WERE NOT UTILIZED IN A PATIENT PROCEDURE AND ARE ONLY INSTRUMENTS USED FOR DEMONSTRATIONS. A HU-FRIEDY REPRESENTATIVE WHO WAS PRESENT DURING THE TIME OF THE REPORTED EVENT DOES NOT RECALL THE USER FACILITY EMPLOYEE GETTING "POKED" BY AN INSTRUMENT. HU-FRIEDY IS NOT ABLE TO CONFIRM A SPECIFIC SHOWCASE INSTRUMENT THE USER FACILITY'S EMPLOYEE CLAIMED TO HAVE BEEN "POKED" BY AND DOES NOT BELIEVE THE EMPLOYEE WAS "POKED" BY ONE OF THE SHOWCASE INSTRUMENTS. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED AN EMPLOYEE WAS "POKED" BY A SHOWCASE INSTRUMENT WHILE HANDLING AN INSTRUMENT CASSETTE. THE EMPLOYEE SOUGHT MEDICAL TREATMENT.