INVESTIGATION FINDINGS: THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR RETURN, AND THERE WAS NO LOT NUMBER LISTED IN THE COMPLAINT INFORMATION. PRODUCT ON HAND WAS REVIEWED AT RANDOM, THERE WAS NO MANUFACTURING ERRORS/DEFECTS FOUND. THE COMPLAINT TO SALES RATIO FOR PRODUCT RUBBING ON SKIN FOR JULY 2014 TO JULY 2016 IS (B)(4). THE INVESTIGATOR FOLLOWED UP WITH SALES REPRESENTATIVE TO INQUIRE ON THE NATURE OF THE "SKIN BREAKDOWN" REPORTED. SKIN BREAKDOWN IS A GENERIC TERM THAT COULD MANY TYPES OF SKIN INJURY. THE CUSTOMER VERBALLY RELAYED THE FOLLOWING INFORMATION TO THE SALES REPRESENTATIVE. THE PATIENT DEVELOPED PRESSURE SORES AT THE TOP TO THE CHEST AND THE JAW. THESE WERE CAUGHT EARLY AND PATIENT WAS EQUIPPED WITH ANOTHER PRODUCT. ROOT CAUSE: INVESTIGATION TEAM WAS UNABLE TO DETERMINE ROOT CAUSE AS THE COMPLAINT SAMPLE WAS NOT RETURNED. CORRECTIONS: CREDIT WAS REQUESTED/ISSUED. CORRECTIVE ACTION: THERE WERE NO MANUFACTURING DEFECTS FOUND IN HOUSE AND NO ROOT CAUSE WAS DETERMINED, THEREFORE NO CORRECTIVE ACTION IS NEEDED AT THIS TIME. PREVENTIVE ACTION: THERE IS NO PREVENTIVE ACTION REQUIRED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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Patient 1
THE QUALITY ISSUE DETAILS AND THE OUTCOME DETAILS SECTION COPIED BELOW ARE RESPONSES GIVEN BY THE INITIAL REPORTER TO THE DEROYAL COMPLAINT QUESTIONNAIRE. QUALITY ISSUE DETAILS: DATE OF OCCURRENCE: (B)(6) 2016. WHEN DID QUALITY ISSUE OCCUR? DURING USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? HEALTH PROFESSIONAL. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE. DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: PATIENT STATED THAT COLLAR WAS VERY UNCOMFORTABLE WHERE IT MET THE UPPER CHEST, SKIN BREAKDOWN WAS OBSERVED. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? USED TO IMMOBILIZE PATIENTS HEAD AND NECK. WAS IT THE INITIAL USE OF THE PRODUCT? NO. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO. OUTCOME DETAILS: OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: IRRITATION, REACTION, RASH. DETAILS OF IRRITATION, REACTION, RASH (SEVERITY, MEDICAL TREATMENT, ETC.): SKIN BREAKDOWN. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: PATIENT. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? DON'T KNOW. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: (B)(6), GOT A REPLACEMENT COLLAR TO TRY, PATIENT REFUSED TO WEAR.