ADVANTAGE SALIVA EJECTORS ¿ DISPOSABLE, 100/PKG
Received Apr 27, 2023
Report MW5117102 · MDR key 16832765
Device
Generic name
Mouthpiece, Saliva Ejector
Manufacturer
Crosstex International, Inc.Catalog number
235-4629
Lot number
2072334
Product problems
- Break
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 04-APR-2024, FOR MW5117102. THIS IS AN UPDATE TO AN EXISTING MDR TO ADD INFORMATION THAT WAS OBTAINED FOLLOWING THE ORIGINAL SUBMISSION. NEW INFORMATION WILL BE PRECEDED WITH "NEW" TO IDENTIFY NEW INFORMATION BEING ADDED TO THE REPORT. PROBLEM: THE PRODUCT BREAKS OFF WHEN IN USE AND THE DENTAL CLINIC HAD TWO PATIENTS SWALLOW IT. THE STAFF WAS ABLE TO RETRIEVE 3 OTHERS OUT OF PATIENT MOUTHS PRIOR TO SWALLOWING. RESULTS: UPON NOTIFICATION OF THIS COMPLAINT TO THE MANUFACTURER, THEIR QUALITY ASSURANCE TEAM COMPLETED THE REVIEW OF THE PRODUCT. AS PER THE MANUFACTURER, THE PRODUCT RETAINS OF THE REPORTED LOT WERE EVALUATED AND NO ISSUES WERE NOTED. THE PRODUCT OF THAT LOT WAS RETURNED AND BASED ON THE EVALUATION NO SPECIFIC ROOT CAUSE COULD BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT OF THE ITEM AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE PRODUCT IS BREAKING OFF WHEN IN USE AND THEY EVEN HAD A PATIENT THAT SWALLOWED IT.