RUBBER DAM PUNCH
Received Oct 21, 2020 · Event occurred Sep 23, 2020
Report 2523190-2020-00118 · MDR key 10715798
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
A CUSTOMER REPORTED THAT THE TIP OF THE 766A RUBBER DAM PUNCH BROKE OFF IN A PATIENT'S MOUTH DURING AN UNSPECIFIED DENTAL PROCEDURE ON (B)(6) 2020. THEY WERE ABLE TO RETRIEVE IT WITHOUT CAUSING HARM TO THE PATIENT. THERE WAS NO KNOWN DELAY IN SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Description of Event or Problem
N/A.
Additional Manufacturer Narrative
UPDATED FIELDS: D10, G4, G7, H2, H3, H6, H10. UDI#: (B)(4). THE RUBBER DAM PUNCH WAS NOT RETURNED (DISCARDED BY CUSTOMER) AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
Additional Manufacturer Narrative
UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). 766A RUBBER DAM PUNCH WAS RECEIVED FOR EVALUATION. THE RETURNED RUBBER DAM PUNCH WAS IN USED CONDITION WITH THE TIP BROKEN OFF DUE TO PHYSICAL DAMAGE. THE REPORTED COMPLAINT IS CONFIRMED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.