REACH

Additional Manufacturer Narrative

THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

Description of Event or Problem

AN INITIAL SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA PHONE SURVEY ON 19-NOV-2024 AND ADDITIONAL INFORMATION RECEIVED ON 27-NOV-2024. A 42-YEAR-OLD MALE USED REACH MINT WAXED FLOSS ON (B)(6) 2024 (LOT NUMBER 14224D). THE INDIVIDUAL'S PAST MEDICAL HISTORY WAS NOT REPORTED. THE INDIVIDUAL'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE INDIVIDUAL'S CO-SUSPECTS WERE NOT REPORTED. ON (B)(6) 2024, REPORTED AS WHEN THE INDIVIDUAL WAS FLOSSING THE FLOSS CAUSED HIS TOP BACK MOLAR TO CHIP A PORTION OF HIS TOOTH AND FALLEN INTO BATHROOM SINK COUNTER. THE INDIVIDUAL STATED THAT WHEN THEY CHECKED THE FLOSS IT FELT TO BE ROUGH AND THIN AND DOES NOT APPEAR TO HAVE WAXED COATING. REPORTEDLY, THE INDIVIDUAL HAS BEEN USING REACH MINT WAXED FLOSS EVERY NIGHT FOR YEARS. THE INDIVIDUAL REPORTEDLY HAS 2 CROWNS, HOWEVER THE CHIPPED TOOTH DOES NOT HAVE ANY PROSTHESIS. ON (B)(6) 2024, THE INDIVIDUAL CONSULTED THEIR DENTIST TO GET THE TOOTH FIXED. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TREATMENT INCLUDED ONLAY FIXTURE DONE ON TOOTHTH NUMBER 14 ODLB (CODE 2644). THE OUTCOME OF THE EVENT WAS RECOVERED. FURTHER INFORMATION IS EXPECTED UPON PRODUCT RETURN FROM CONSUMER. COMMENTS: REVIEW OF THE COMPLAINT DATA REVEALED NO UNFAVORABLE TRENDS FOR THE REPORTED LOT NUMBER OR PRODUCT. BASED ON THE ANALYSIS OF THIS PRODUCT AND COMPLAINT IT WILL BE MANAGED THROUGH MONTHLY TREND ANALYSIS AND WILL CONTINUE TO BE MONITORED. THIS SPONTANEOUS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. BASED ON THE AVAILABLE INFORMATION THE COMPLAINT INVESTIGATION IS UNDER PROCESS WITH A DISPOSITION OF UNDETERMINED AND WILL BE UPDATED WITH ANY SIGNIFICANT INFORMATION RECEIVED. FOLLOW-UP RECEIVED ON 27-MAR-2025: THE DATE OF THIS SUBMISSION IS 02-APR-2025. UPON FURTHER INVESTIGATION OF THE RETAINED LOTS NO DEFECTS WERE IDENTIFIED, NOR ANYTHING THAT COULD BE RELATED TO THE INCIDENT REPORTED. CUSTOMER SAMPLE WAS NEVER RETURNED UPON FOLLOW-UP AND HENCE THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

Description of Event or Problem

AN INITIAL SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA PHONE SURVEY ON 19-NOV-2024 AND ADDITIONAL INFORMATION RECEIVED ON 27-NOV-2024. A 42-YEAR-OLD MALE USED REACH MINT WAXED FLOSS ON (B)(6) 2024 (LOT NUMBER 14224D). THE INDIVIDUAL'S PAST MEDICAL HISTORY WAS NOT REPORTED. THE INDIVIDUAL'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE INDIVIDUAL'S CO-SUSPECTS WERE NOT REPORTED. ON (B)(6) 2024, REPORTED AS WHEN THE INDIVIDUAL WAS FLOSSING THE FLOSS CAUSED HIS TOP BACK MOLAR TO CHIP A PORTION OF HIS TOOTH AND FALLEN INTO BATHROOM SINK COUNTER. THE INDIVIDUAL STATED THAT WHEN THEY CHECKED THE FLOSS IT FELT TO BE ROUGH AND THIN AND DOES NOT APPEAR TO HAVE WAXED COATING. REPORTEDLY, THE INDIVIDUAL HAS BEEN USING REACH MINT WAXED FLOSS EVERY NIGHT FOR YEARS. THE INDIVIDUAL REPORTEDLY HAS 2 CROWNS, HOWEVER THE CHIPPED TOOTH DOES NOT HAVE ANY PROSTHESIS. ON (B)(6) 2024, THE INDIVIDUAL CONSULTED THEIR DENTIST TO GET THE TOOTH FIXED. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TREATMENT INCLUDED ONLAY FIXTURE DONE ON TOOTH NUMBER 14 ODLB (CODE 2644). THE OUTCOME OF THE EVENT WAS RECOVERED. FURTHER INFORMATION IS EXPECTED UPON PRODUCT RETURN FROM CONSUMER. COMMENTS: REVIEW OF THE COMPLAINT DATA REVEALED NO UNFAVORABLE TRENDS FOR THE REPORTED LOT NUMBER OR PRODUCT. BASED ON THE ANALYSIS OF THIS PRODUCT AND COMPLAINT IT WILL BE MANAGED THROUGH MONTHLY TREND ANALYSIS AND WILL CONTINUE TO BE MONITORED. THIS SPONTANEOUS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. BASED ON THE AVAILABLE INFORMATION THE COMPLAINT INVESTIGATION IS UNDER PROCESS WITH A DISPOSITION OF UNDETERMINED AND WILL BE UPDATED WITH ANY SIGNIFICANT INFORMATION RECEIVED.