HYGENIC
Received Sep 13, 2018 · Event occurred Mar 20, 2018
Report 2416455-2018-09131 · MDR key 7873960
Device
Product problems
- Break
- Product Quality Problem
- Material Integrity Problem
- Material Integrity Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ACCORDING TO THE DENTIST, THE PRODUCT BREAKS VERY EASILY AND CAN NOT BE USED. DAM BROKE DURING PROCEDURE.
Additional Manufacturer Narrative
CUSTOMER STATES THEY RECEIVED (1) BOX OF H02146 DENTAL DAM, LOT 191J1, THAT TEARS EASILY. THE CUSTOMER DID NOT RETURN ANY PRODUCT FOR ANALYSIS. COMPLAINT ANALYSIS: COMPLAINT HISTORY ANALYSIS SHOWS NO ADDITIONAL COMPLAINTS FOR THIS BATCH. INVENTORY ANALYSIS SHOWS NO REMAINING PRODUCT IN STOCK OF THIS LOT NUMBER. SAP SHOWS STOCK OF THIS BATCH WAS DEPLETED 01/25/2018. ROOT CAUSE ANALYSIS: WHY? CUSTOMER STATES PRODUCT RECEIVED TEARS EASIER THAN INTENDED. WHY? CUSTOMER IS DISSATISFIED WITH THE MATERIAL STRENGTH OF THE DENTAL DAM. WHY? CUSTOMER EXPECTATIONS DO NOT MEET FINAL DELIVERED PRODUCT QUALITY. WHY? DENTAL DAM MAY HAVE BEEN HEATED/COOLED DURING TRANSPORTATION OR STORAGE, WEAKENING THE MATERIAL PROPERTIES. WHY? EXPOSURE TO EXTREME TEMPERATURES (HIGH/LOW) IS KNOWN TO ACCELERATE DETERIORATION AND LOWER THE SHELF LIFE OF THE PRODUCT. THE DENTAL DAM TORE DURING PROCEDURE. CAPA ASSESSMENT: CAPA NOT REQUIRED AT THIS TIME. THIS LOT WILL CONTINUE TO BE MONITORED FOR FURTHER OCCURRENCES.
Remedial action
- Replace