ON (B)(6) 2012, AN OPERATING ROOM MANAGER FROM (B)(6) HOSPITAL OF (B)(6), CONTACTED AN ALLEN REPRESENTATIVE TO REPORT A NON-PERMANENT PATIENT INCIDENT WHICH REQUIRED TREATMENT. THE SUBJECT OF THE CASE WAS A FEMALE PATIENT HAVING SPINE SURGERY ON (B)(6) 2012, WHICH LASTED APPROXIMATELY FIVE HOURS. THE PATIENT, WHO IS REPORTEDLY ALLERGIC TO LATEX, DEVELOPED A POST-OPERATIVE RASH ON HER FACE WHERE IT CONTACTED THE ALLEN COMFORT MASK. THE STAFF REPORTED THE PATIENT RASH WAS TREATED TOPICALLY AND WAS REPORTEDLY SUBSIDING A WEEK LATER WHEN IT WAS REPORTED TO THE ALLEN REP.
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Patient 1
IT IS UNCLEAR IF THE PATIENT WAS PREPPED OR THE SURFACES CLEANED WITH A SUBSTANCE WHICH COULD HAVE CAUSED THE REACTION - OR IF THERE WAS SIGNIFICANT MOVEMENT DURING THE FIVE-HOUR CASE WHICH COULD HAVE CAUSED THIS REACTION. THE SINGLE USE DISPOSABLE PRODUCT IS LATEX-FREE. THIS WAS VERIFIED BY THE MATERIAL VENDOR. THE SUBJECT PRODUCT AND UNUSED PRODUCT FROM THE SAME CASE OR LOT WAS NOT RETURNED TO US BY THE CUSTOMER FOR THIS INVESTIGATION. THE PATIENT WAS SAID TO BE RECOVERING A WEEK AFTER THE REPORT, WHEN IT WAS REPORTED. FULL RECOVERY COULD NOT BE CONFIRMED AS THE REPORTER HAS NOT YET ANSWERED OUR CONTACT ATTEMPTS. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.