BALLARD* 24-HOUR ORAL CARE KIT

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 19 DEC 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

Description of Event or Problem

IT WAS REPORTED: THAT THE SPONGE IS COMING FROM THE PLASTIC STICK AND GETTING STUCK IN THE PATIENT'S MOUTH.

Description of Event or Problem

IT WAS REPORTED: THAT THE SPONGE IS COMING FROM THE PLASTIC STICK AND GETTING STUCK IN THE PATIENT'S MOUTH.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 19 DEC 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. RISK ASSESSMENT.: THE ULTIMATE RISK IS MEDIUM, AS THAT IS THE HIGHEST RISK OF THE PATIENT/CAREGIVER AND REGULATORY/COMPLIANCE CONSIDERATIONS: 1.PATIENT/CAREGIVER PERFORMED RISK ASSESSMENT WITH DHFE-06243 REVISION 5; THE MOST CLOSELY ASSOCIATED HAZARD IS HZD009-02 "DEFECTIVE COMPONENTS" HAZARDOUS SITUATION: "COMPONENT BREAKS/DETACHED" WITH A PROBABILITY OF HARM OCCURRING (P)= 1-IMPROBABLE AND SEVERITY (S)=4-SEVERE WHICH IS MEDIUM RISK. THE CALCULATED P1 BASED ON COMPLAINTS AND SALES IN THE PREVIOUS 24 MONTHS IS 0.000088% CORRESPONDING TO IMPROBABLE. THEREFORE, THE PROBABILITY OF HARM OCCURRING (P) REMAINS THE SAME AS THE RMA AND IS DETERMINED TO BE MEDIUM RISK PER REF-20001-C1 REV#2. 2. REGULATORY/ COMPLIANCE REVIEWED REF-20001-C1 REV#2, AND THERE IS LOW REGULATORY/ COMPLIANCE RISK. 3. BRAND RECOGNITION AND CUSTOMER IMPACT REVIEWED REF-20001-C1 REV#2, AND THERE IS LOW BRAND RECOGNITION/CUSTOMER IMPACT DEVICE HISTORY RECORD (DHR) REVIEW. BASED ON THE DEVICE HISTORY RECORD (DHR) REVIEW THERE WERE NO ABNORMAL PROCESSING ISSUES NOTED. ALL PRODUCTS/PACKAGING WERE PRODUCED PER THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND INSPECTIONS. COMPLAINT HISTORY REVIEW: A. THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM REPORTED DATES (B)(6) 2023 THROUGH (B)(6) 2025, FOR PART NUMBER 97012 AND FAILURE MODE "SPONGE COMES APART/COMES OFF". THERE. WERE 4 OTHER COMPLAINTS REPORTED FOR THE SAME ISSUE AND PART NUMBER UNDER COMPLAINT (B)(4), DURING THE SAME TIMEFRAME. SALES = (B)(4) EA. CALCULATED OCCURRENCE (P1) = (5 COMPLAINTS / (B)(4) EA SOLD) X 100 = (B)(4). OCCURRENCE RANKING = IMPROBABLE.