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Patient 1
EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION RECEIVED ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AN ENGINEERING REVIEW OF THE PRODUCT, AND AN EVALUATION OF THE RETURNED DEVICE. UNIT WAS RECEIVED DISMANTLED WITH MISSING COMPONENTS; ONLY THE TUBE HOUSING ASSEMBLY, TRIGGER RELEASE, TRIGGER AND COVER WERE RECEIVED. GOOD WELDING WAS OBSERVED ON COVER. UNIT CONDITION PRECLUDES ANY FUNCTIONAL VERIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED AS A RESULT OF THE ALLEGED EVENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME. (B)(4).