ROSCOE

Description of Event or Problem

THE END USER RECEIVED TREATMENT THAT CAUSED TEMPORARY IMMOBILITY WHERE THE TREATMENT WAS PERFORMED. THE END USER HAS HAD SEVERAL DOCTOR VISITS WHERE SHE WAS PRESCRIBED ANTI-INFLAMMATORY MEDICATION. AS REPORTED BY THE END USER THE ELECTRODES WERE PLACED LESS THAN 1" APART. THE ELECTRODES THAT WERE BEING USED WERE NOT CHB ELECTRODES.

Additional Manufacturer Narrative

THIS EVENT WAS ALSO REPORTED TO FDA BY THE IMPORTER UNDER IMPORTER REPORT NO. 3012316249-2025-00009. (1) INVESTIGATION METHODOLOGY: A COMPLAINT INVESTIGATION WAS INITIATED. THE MANUFACTURER REVIEWED THE DEVICE HISTORY RECORDS (DHR) FOR OTHER BATCH SINCE NO SERIAL NUMBER WAS PROVIDED AND DID NOT IDENTIFY OUTPUT ABNORMALITIES RECORDED DURING PRODUCTION OR TESTING. (2) FAILURE MODE/MECHANISM CONSIDERATIONS: A DEFINITIVE DEVICE FAILURE MODE COULD NOT BE CONFIRMED BASED ON CURRENTLY AVAILABLE INFORMATION. THE REPORTED USE CONDITIONS[?]VERY CLOSE ELECTRODE SPACING (<1") AND USE OF NON-CHB ELECTRODES[?]MAY AFFECT ELECTRODE-SKIN INTERFACE CHARACTERISTICS (EFFECTIVE CONTACT AREA, CURRENT DENSITY, IMPEDANCE/CONTACT QUALITY) AND COULD PLAUSIBLY CONTRIBUTE TO LOCALIZED ADVERSE EFFECTS.THE DHR REVIEW DID NOT IDENTIFY MANUFACTURING/TEST-RECORDED OUTPUT ABNORMALITIES. (3) CONCLUSIONS: BASED ON THE INFORMATION AVAILABLE, ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. ELECTRODE SPACING THAT IS TOO CLOSE (<1 INCH) AND THE USE OF NON-CHB ELECTRODES MAY BE POTENTIAL CAUSES OF THE PROBLEM. THE DHR REVIEW DID NOT REVEAL OUTPUT ABNORMALITIES RECORDED DURING PRODUCTION OR TESTING. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF MORE INFORMATION BECOMES AVAILABLE.