PATTERSON SALIVA EJECTORS
Received Nov 7, 2019 · Event occurred Sep 24, 2019
Report 9611959-2019-00002 · MDR key 9293334
Device
Generic name
Saliva Ejector
Manufacturer
Patterson Dental Supply Inc.Catalog number
107-3980
Lot number
20190287V-S4
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A PRELIMINARY INVESTIGATION WAS PERFORMED BY THE MANUFACTURER ON THE RETAINED LOT. THE RETAINED LOT CONFORMS TO SPECIFICATIONS. NO ROOT CAUSE HAS BEEN IDENTIFIED.
Description of Event or Problem
A PRODUCT COMPLAINT ((B)(4)) WAS REPORTED TO AMD MEDICOM ON (B)(6) 2019 FOR PATTERSON DENTAL SUPPLY INC. BRAND PRODUCT SALIVA EJECTOR. ITEM CODE 107-3980, LOT NUMBER 20190287V-S4. THE SALIVA EJECTOR IS CLASSIFIED AS CLASS I MEDICAL DEVICE UNDER FDA CODE DYN. SALIVA ELECTORS ARE USED IN DENTISTRY IN ORDER TO REMOVE SALIVA, BLOOD OR OTHER DEBRIS FROM THE MOUTH DURING DENTAL PROCEDURES. THIS DISPOSABLE DEVICE IS CONNECTED TO AN ACTIVE DEVICE, NORMALLY A PNEUMATIC SYSTEM SUCTION CIRCUIT. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED: "THE TIP/HEAD OF THE SALIVA EJECTOR CAME OFF IN PATIENT'S MOUTH. THIS HAPPENED TO SEVERAL PATIENTS. CHOKING HAZARD".