SURGICAL GOWNS

Additional Manufacturer Narrative

RETURNED GOWN WAS TESTED FOR PH, WHICH SHOWED TO BE NEUTRAL. CUFFS AND SLEEVES WERE SOAKED IN WARM WATER TO CHECK FOR PRESENCE OF EXCESSIVE DETERGENT RESIDUE (SUDSING) WHERE WATER APPEARED CLEAR AND SHOWED NO SIGNS OF EXCESSIVE DETERGENT RESIDUE. DAILY BOILER AND SOFTENER LOGS AND TITRATION REPORTS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM THE ORIGINAL SPECIFICATIONS. THE TITRATION REPORTS ALSO SHOWED NO DEVIATIONS FROM THE SPECIFICATIONS. A PH TEST AND AN EXCESSIVE DETERGENT RESIDUE CHECK ON PRODUCT THAT WAS RANDOMLY PULLED FROM ON-HAND INVENTORY MATCHED THE RETURNED GOWN TEST AND OBSERVATIONS RESULTS (NEUTRAL PH AND NO SUDSING OF WATER). TECHNICIAN HAS BEEN WEARING THE SAME TYPE GOWNS (REFERENCE MODEL #7004X) WITHOUT PROBLEMS SINCE (B)(6) 2015. BECAUSE WE CANNOT IDENTIFY ANY OTHER EVIDENCE OF A PROCESS DEVIATION AND BASED ON THE FACT THAT ALL OTHER RESULTS ARE WITHIN SPECIFICATIONS, AND HAVE NO OTHER COMPLAINTS BEING REPORTED, WE HAVE DETERMINED THAT THIS WAS AN ISOLATED INCIDENT.

Description of Event or Problem

SURGICAL TECHNICIAN NOTICED WELTS AND HIVES ON BOTH WRISTS AND ARMS WHILE WEARING LP (LEVEL 4) SURGICAL GOWN. EMPLOYEE HEALTH DEPARTMENT PRESCRIBED AND ADMINISTERED ZYRTEC PILLS AND 1% HYDROCORTISONE CREAM TO ALLEVIATE ITCHING AND SWELLING/REDNESS.