CHATTANOOGA
Received May 31, 2026 · Event occurred May 4, 2026
Report 9616086-2026-00023 · MDR key 25342861
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
45 YR · Male
- Burn(s)
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT SUSTAINED A BURN DURING TREATMENT. TREATMENT/PLAN: LIDOCAINE 2% TO WOUND BEDS X 5 MINUTES. AREAS CLEANSED. DEBRIDEMENT OF WOUND BED WITH STERILE CURRETTE WITH PT PERMISSION, FULL THICKNESS. NO STING SKIN BARRIER TO PERIWOUND AREA. SILVADENE CREAM TO MEPILEX BORDER DRSG AND APPLIED TO WOUND BED. PT INSTRUCTED ON DRSG CHANGES DAILY. SUPPLIES SENT AND ORDERED. 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 SUSTAINED A BURN DURING TREATMENT.