CMF
Received Aug 22, 2025 · Event occurred Jul 21, 2025
Report 9616086-2025-00058 · MDR key 22879929
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TRANDUCER GETS HOT BURNS SKIN AND WEIGHTED STRAP ALSO BURNING SKIN. THE PATIENT TREATED THE BURN WITH VASALINE.
Additional Manufacturer Narrative
IT WAS REPORTED THAT TRANDUCER GETS HOT BURNS SKIN AND WEIGHTED STRAP ALSO BURNING SKIN. THE PATIENT TREATED THE BURN WITH VASALINE. THE DEVICE WAS RETURNED FOR EVALUATION, THE RESULTS OF HUMAN TESTING/POWER TESTING/HYDROPHONE TESTING WERE ALL NORMAL, AND THERE WERE NO SIMILAR CUSTOMER COMPLAINTS; THE CUSTOMER'S USE OTHER STRAP WHICH IS NOT ACCESSORY OF MANAFUSE TO FIX THE ULTRASOUND HEAD, AND IT CANNOT BE RULED OUT THAT THERE MAY BE SITUATIONS WHERE THE HUMAN ALLERGY/BIOCOMPATIBILITY TEST DOES NOT MEET THE REQUIREMENTS. IF ADDITIONAL REPORTING ON THIS EVEN IS PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.