FLUIDOTHERAPY FT110 SINGLE
Received Sep 27, 2021 · Event occurred Sep 8, 2021
Report 9616086-2021-00015 · MDR key 12536571
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A SEVERE, ALLERGIC REACTION AFTER HER FLUIDOTHERAPY TREATMENT. THE REACTION WAS NOT IMMEDIATE. IT WAS REPORTED THAT SOMETIME BETWEEN THE FLUIDOTHERAPY TREATMENT AND WHEN THE PATIENT ARRIVED TO WORK, THE ALLEGED REACTION OCCURRED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWELLING OF HER TONGUE AND LIPS AND REQUIRED A TRANSFER TO THE HOSPITAL. DJO HAS BEEN INFORMED THE PATIENT HAS AN ALLERGY TO SULFUR. DJO CONTINUES TO INVESTIGATE AND WILL PROVIDE A SUPPLEMENTAL ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A SEVERE, ALLERGIC REACTION AFTER HER FLUIDOTHERAPY TREATMENT.