ADVANTAGE SALIVA EJECTOR
Received May 25, 2023 · Event occurred Mar 20, 2023
Report 1319130-2023-00004 · MDR key 17008318
Device
Generic name
Saliva Ejector
Manufacturer
Spsmedical Supply Corp. A Div. Of Crosstex Intl.Model number
ZWWILot number
2072334
Product problems
- Break
- Break
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
FOLLOWING THE REPORTED EVENT, PRODUCT RETAINS FROM THE REPORTED LOT WERE EVALUATED AND NO ISSUES WERE NOTED. DEVICES FROM THE SAME LOT WERE RETURNED TO CROSSTEX FOR EVALUATION. BASED ON THE EVALUATION, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. CROSSTEX WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.
Description of Event or Problem
THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT # MW5117102 THAT DURING FIVE DIFFERENT DENTAL PROCEDURES THE TIP OF THEIR ADVANTAGE SALIVA EJECTOR BROKE OFF. IN TWO CASES, THE TIP DETACHED AND WAS SWALLOWED BY THE PATIENT. THESE PATIENTS WERE ADVISED BY THE USER FACILITY TO SEEK MEDICAL ATTENTION AND LET THE FACILITY KNOW IF THERE WERE ANY ISSUES. IN THE REMAINING THREE CASES, THE TIP DETACHED AND ALL COMPONENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT'S MOUTH. THERE WAS NO REPORT OF INJURY FOR ANY OF THE CASES.