CHATTANOOGA
Received Mar 5, 2025 · Event occurred Sep 24, 2024
Report 9616086-2025-00022 · MDR key 21532028
Device
Generic name
Vectra Genisys 2ch Combo, Us Std W/cart
Manufacturer
Djo LlcCatalog number
2792
Lot number
T3000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING ELECTRICAL STIMULATION, UPON COMPLETION OF TREATMENT AND INSPECTION OF SKIN AFTER ELECTRICAL STIMULATION. THE PHYSICAL THERAPIST ASSISTANT NOTED SKIN ALTERATIONS AND NOTIFIED THEIR SUPERVISOR OF THE FINDINGS. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THE ROOD CAUSE COULD NOT BE ESTABLISHED. IF MORE INFORMATION BECOMES AVAILABLE ADDITIONAL REPORTING WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING ELECTRICAL STIMULATION, UPON COMPLETION OF TREATMENT AND INSPECTION OF SKIN AFTER ELECTRICAL STIMULATION. THE PHYSICAL THERAPIST ASSISTANT NOTED SKIN ALTERATIONS AND NOTIFIED THEIR SUPERVISOR OF THE FINDINGS.