N
Patient 1
FURTHER INFORMATION WAS REQUESTED FROM THE PATIENT WHO WAS THE INITIAL REPORTER OF THIS ADVERSE EVENT. THE FACILITY NAME WAS PROVIDED AND NATUS ATTEMPTED TO CONTACT THIS FACILITY ON NUMEROUS OCCASIONS THROUGH PHONE FOR FURTHER INFORMATION (PART NUMBER / LOT NUMBER ETC.). NO RESPONSE TO ANY OF NATUS VOICEMAILS WERE RECEIVED. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: RELEVANT TESTS / LABORATORY DATA - THE PATIENT WAS ASKED THIS QUESTION BUT DID NOT PROVIDE THIS INFORMATION. NATUS HAS ATTEMPTED TO CONTACT THE FACILITY ON NUMEROUS OCCASIONS BUT NO RESPONSE HAS BEEN RECEIVED. SUSPECT PRODUCTS - NOT APPLICABLE. MODEL #, CATALOG #, LOT#, EXPIRATION DATE, UNIQUE IDENTIFIER - DEFECT PART NUMBER AND LOT NUMBER REQUESTED FROM THE PATIENT BUT THIS INFORMATION WAS NOT AVAILABLE TO THE PATIENT. NATUS HAS ATTEMPTED TO CONTACT THE FACILITY ON NUMEROUS OCCASIONS BUT NO RESPONSE HAS BEEN RECEIVED. 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. INITIAL REPORTER - INITIAL REPORTER IN THIS CASE WAS THE PATIENT. NO INFORMATION ON THE PATIENTS ADDRESS. THE FACILITY ESTABLISHMENT ADDRESS IS AS FOLLOWS: (B)(6). FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. PMS/510(K) - NOT APPLICABLE - PRE-AMENDMENT. 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. DEVICE MANUFACTURE DATE - UNKNOWN DEVICE LOT NUMBER TO DETERMINE MANUFACTURE DATE 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 21 USC 360I(F).