ABVISER® AUTOVALVE® IAP MONITORING DEVICE

Additional Manufacturer Narrative

THE COMPLAINT SAMPLE WAS RETURNED HOWEVER, AN EVALUATION WAS NOT PERFORMED AND IS PENDING. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.NO ADDITIONAL DETAILS OR PATIENT DATA HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.(B)(4).

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. A USED DEVICE WAS RETURNED FOR EVALUATION; HOWEVER NO MODEL OR LOT NUMBER WAS AVAILABLE. THE DEVICE WAS SENT TO THE MANUFACTURER FOR EVALUATION. NO ADDITIONAL DETAILS OR PATIENT DATA HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON MARCH 02, 2016. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE FAILED TO DEFLATE. THERE WAS ONE (1) LITER OF URINE FOUND IN THE PATIENT'S BLADDER, WHEN THE ISSUE WAS NOTICED. NO LAB TEST WERE CONDUCTED. THE BLADDER WAS DRAINED WITHOUT ISSUE AFTER THE DEVICE WAS DISCONTINUED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016, NOTING THAT THE PATIENT HAD A BLOOD CLOT THAT FORMED RIGHT AT THE ABVISER BALLOON AND WAS CLOTTED OFF AND THERE WAS NO DEVICE MALFUNCTION NOTED. THERE WAS NO PATIENT HARM REPORTED.