HYGENIC DENTAL DAM THIN GREEN

Description of Event or Problem

THE CUSTOMER INITALLY REPORTED THAT THE DENTAL DAM TEARS VERY QUICKLY. IT WAS CONFIRMED ON (B)(6) 2021 THAT THE DENTAL DAM TORE DURING TREATMENT AND THAT THE ROOT CANAL TREATMENT HAD TO BE RESTARTED. THE CUSTOMER WAS CONTACTED ON (B)(6) 2021 TO OBTAIN ADDITIONAL INFORMATION REGARDING ANY OTHER MEDICAL DEVICES THAT WERE BEING USED AT THE TIME OF THE INCIDENT AND TO DETERMINE THE NUMBER OF PATIENTS THAT WERE AFFECTED. DURING THIS FOLLOW UP, IT WAS DETERMINED THAT AN ADVERSE EVENT DID NOT ACTUALLY OCCUR. THE DENTIST INDICATED THAT THE DENTAL DAM TORE PRIOR TO PROCEDURE AND WAS JUST PROVIDING AN EXAMPLE OF WHAT COULD HAVE HAPPENED IF THE DENTAL DAM WOULD HAVE TORN DURING PROCEDURE (RESTART THE ROOT CANAL TREATMENT).

Additional Manufacturer Narrative

INVESTIGATION OF THE RETURNED PRODUCT: TYPICAL VALUES FOR FRESHLY PRODUCED DENTAL DAM ARE TENSILE GREATER THAN OR EQUAL TO 3,500 LBF/IN² AND ULTIMATE ELONGATION GREATER THAN OR EQUAL TO 700% WITH REFERENCE TO TYPICAL MODULUS AT 100% ELONGATION @ 120 LBF/IN². PROPERTIES WILL DETERIORATE AS THE DAM AGES. THE MEAN VALUE FOR TENSILE IS 3,907 LBF/IN² WHICH IS WITHIN SPECIFICATION FOR NEWLY PRODUCED DENTAL DAM AS WELL AS ULTIMATE ELONGATION AT 743% WITH 111 LBF/IN² AS THE MODULUS AT 100% LBF/IN² FROM THE DATA PRODUCED, IT IS DETERMINED THAT THE DENTAL DAM IS AS EXPECTED AND NO ABNORMAL RESULTS WERE FOUND. THE FIT, FORM AND FUNCTION OF THE DAM IS NOT COMPROMISED. A REVIEW OF PAST COMPLAINTS WAS PERFORMED REGARDING TEARS FOR THIS SHEETING LOT FROM AUGUST 2019 UNTIL PRESENT. THIS IS THE FIRST COMPLAINT RECORDED FOR THIS LOT/PART; THEREFORE, NO RECURRENCE WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER INITIALLY REPORTED THAT THE DENTAL DAM TEARS VERY QUICKLY. IT WAS CONFIRMED ON (B)(6) 2021 THAT THE DENTAL DAM TORE DURING TREATMENT AND THAT THE ROOT CANAL TREATMENT HAD TO BE RESTARTED.