MICROTEK MEDICAL

Additional Manufacturer Narrative

(B)(4) COMPLAINT DEPARTMENT HAS CONTACTED (EMAIL AND CALLED) THE USER FACILITY, (B)(4), TWO TIMES PER THE FOLLOWING DATES: (B)(6) 2015, (B)(6) 2015. THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY TO THE (B)(4) COMPLAINT DEPARTMENT. NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS THE ROOT CAUSE FOR THE EVENT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

Description of Event or Problem

THERE WAS A MEDWATCH REPORTED BY (B)(4) TO FDA. (B)(4) RECEIVED THE REPORT ON (B)(6) 2015. THE REPORT STATED THAT THERE WAS A HOLE IN THE IRRIGATION WARMING DRAPE THAT CONTAMINATED THE IRRIGATION USED ON THE BRAIN; LEADING TO A CONTAMINATED CASE. CANCO POWDER WAS APPLIED TO THE BRAIN AFTER IRRIGATION WITH FRESH SOLUTION. THE OUTCOME IS UNKNOWN BUT THERE IS AN INCREASED RISK OF INFECTION.