BIOMET EBI BONE HEALING SYSTEM SFLX- XL THERAPEUTIC TREATMENT COILETTE
Received May 1, 2025
Report 0002242816-2025-00063 · MDR key 21946233
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
76 YR · Female
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
B3: AS EXACT DATE OF EVENT IS UNKNOWN, ESTIMATED DATE OF EVENT IS APRIL 2025. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW UP REPORT WILL BE SENT.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT INDICATED THAT THEY EXPERIENCED PAIN AROUND SEVEN HOURS INTO THE TREATMENT. THE SALES REPRESENTATIVE SUGGESTED TIME-TEST STARTING AT SIX HOURS OR IF SHE HAS PAIN EARLIER TO TAKE IT OFF AT THAT TIME AND REPEAT THE TIME-TEST. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE BHS UNIT AND SFLX- XL COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.
Additional Manufacturer Narrative
B3: AS EXACT DATE OF EVENT IS UNKNOWN, ESTIMATED DATE OF EVENT IS APRIL 2025. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW UP REPORT WILL BE SENT.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT INDICATED THAT THEY EXPERIENCED PAIN AROUND SEVEN HOURS INTO THE TREATMENT. THE SALES REPRESENTATIVE SUGGESTED TIME-TEST STARTING AT SIX HOURS OR IF SHE HAS PAIN EARLIER TO TAKE IT OFF AT THAT TIME AND REPEAT THE TIME-TEST. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE BHS UNIT AND SFLX- XL COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.