N
Patient 1
PATIENT INFORMATION - NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. DATE OF EVENT REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT YET PROVIDED. RELEVANT TESTS / LABORATORY DATA - THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS - NOT APPLICABLE. SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).