BONE GROWTH STIMULATOR
Received Oct 21, 2025 · Event occurred Sep 24, 2025
Report 2183449-2025-00029 · MDR key 23350620
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
51 YR · Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
PATIENT SENT AN EMAIL REPORTING SHE BELIEVES THE DEVICE CAUSED BURNS ON HER BACK. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
ATTEMPTS TO REACH THE PATIENT HAVE BEEN MAD TO GATHER ADDITIONAL DETAILS WITH NO GOOD RESULTS. THE DEVICE HAS BEEN RETURNED FOR EVALUATION BUT THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED - ALL 56 UNITS FROM THIS WORK ORDER PASSED FINAL INSPECTION.
Additional Manufacturer Narrative
ATTEMPTS TO REACH THE PATIENT HAVE BEEN MADE TO GATHER ADDITIONAL DETAILS WITH NO GOOD RESULTS. THE DEVICE WAS RETURNED AND INVESTIGATED. AS RECEIVED, DEVICE WAS ABLE TO POWER ON AND CHARGING AND PASS POST. DEVICE COMPLETED TWO HOURS TREATMENT OF HEATING TEST. NO DAMAGE NOTED TO THE SYSTEM. SYSTEM OPERATES AS DESIGNED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED - ALL (B)(4) UNITS FROM THIS WORK ORDER PASSED FINAL INSPECTION.
Description of Event or Problem
PATIENT SENT AN EMAIL REPORTING SHE BELIEVES THE DEVICE CAUSED BURNS ON HER BACK. NO FURTHER INFORMATION WAS PROVIDED.