THERANOVA

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE, ONE UNIT OF THERANOVA 400 HAD AN EXTERNAL FLUID LEAKAGE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPHS WERE REVIEWED, AND IT WAS NOTED THAT THE PICTURES DID NOT SHOW ANYTHING RECOGNIZABLE AND THEREFORE NO DETAILED INVESTIGATION COULD BE PERFORMED. DUE TO THE ABSENCE OF AN ACTUAL SAMPLE THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.