CHATTANOOGA
Received Apr 30, 2025 · Event occurred Apr 4, 2025
Report 9616086-2025-00048 · MDR key 21940269
Device
Generic name
Vectra Genisys 2ch Combo Pkg Us Std, 5cm Appl
Manufacturer
Djo LlcCatalog number
2761
Lot number
24L129
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR · Male
- Burn(s)
- Unspecified Infection
- Burn(s)
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
SEE D4 SERIAL NUMBER, D9 AND H11. THE DEVICE HAS BEEN RETURNED AND EVALUATED. DEVICE PASSED ALL FUNCTIONAL TESTING AND IS IN GOOD SHAPE. LEAD WIRES WERE TESTED AND SHOW GOOD CONTINUITY. THE ROOT CAUSED COULD HAVE BEEN FROM NOT PROPERLY PREPARING SKIN OR USING OFF BRAND ACCESSORIES COULD CAUSE BURNS UNDER STIM THERAPY.
Additional Manufacturer Narrative
IT WAS REPORTED THAT PATIENT SUSTAINED 5 BURNS WHERE ELECTRODES WERE PLACES DURING TREATMENT THAT WERE TREATED TOPICALLY BY WOUND CARE USING STANDARD BURN CREAM AND INFECTION TREATMENTS. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF MORE INFORMATION BECOMES AVAILABLE ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT SUSTAINED 5 BURNS WHERE ELECTRODES WERE PLACES DURING TREATMENT THAT WERE TREATED TOPICALLY BY WOUND CARE USING STANDARD BURN CREAM AND INFECTION TREATMENTS.