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Patient 1
DISCUS DENTAL RECEIVED A COMPLAINT ON 10/25/2016. THE PATIENT COMPLETED IN-OFFICE TEETH WHITENING PROCEDURE, AND SINCE THEN SHE IS EXPERIENCING TOOTH LINGERING SENSITIVITY. THE PATIENT VISITED A SPECIALIST FOR EVALUATION, WHO FOUND NOTHING WRONG. AFTER RECEIVING THIS REPORT, RETAIN SAMPLE OF THE WHITENING GEL, LOT: 15232022, WAS TESTED AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE GEL AND KIT WERE USED DURING THE PROCEDURE, AND WERE NOT RETURNED. BATCH HISTORY RECORD OF WHITENING GEL SKU: 22-3764, LOT: 15232022 WAS REVIEWED, AND NO OUT OF SPECIFICATIONS, NON-CONFORMANCE OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINT HISTORY. NO OTHER COMPLAINTS WERE RECEIVED WITH THE SAME LOT NUMBER. BASED ON THE INVESTIGATION RESULTS, NO PRODUCT FAILURE OR MALFUNCTION WAS DETECTED. DENTAL OFFICE INFORMED THAT THE PATIENT HAD SCALING AND ROOT PLANNING (SRP) ONE MONTH BEFORE THE WHITENING PROCEDURE. WITH THE AVAILABLE INFORMATION, IT CAN BE CONCLUDED THAT, PRE-EXISTING SENSITIVITY MAY HAVE CONTRIBUTED TO THE LINGERING TEETH SENSITIVITY. IT IS ALSO PLAUSIBLE THAT SCALING AND ROOT PLANNING PRIOR TO THE WHITENING MIGHT HAVE ENHANCED THE SENSITIVITY EXPERIENCE. DFU IS ADEQUATE. PRE-TREATMENT AND POST TREATMENT FOR SENSITIVITY ARE DESCRIBED IN DFU. NO CORRECTIVE ACTION IS REQUIRED. IT ALSO INCLUDES WARNINGS, PRECAUTIONS, AND CANDIDATE QUALIFICATION. DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS. THE WHITENING KIT AND GEL WERE USED.