MalfunctionDYN
DEFEND GENTLE - JECT
Received Oct 20, 2005 · Event occurred Sep 30, 2005
Report 2435126-2005-00001 · MDR key 757079
Device
Generic name
Saliva Ejector
Manufacturer
Mydent InternationalModel number
SE-8000Catalog number
SE-8000
Lot number
*
Product problems
- Loose
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DENTIST CALLED THE SALES REP ADVISING THAT THE TIP OF THE SALIVA EJECTOR HAD COME LOOSE. DENTIST NOTICED THIS WHEN PLACING IN PATIENT'S MOUTH, SO NO HARM WAS INFLICTED.
Additional Manufacturer Narrative
WE PLAN TO CHANGE GLUE TO AN ALTERNATIVE GLUE AFTER WE HAVE TESTED POSSIBLE REPLACEMENTS THOROUGHLY.
Remedial action
- Recall
- Replace