MalfunctionDYN
JOHNSON & JOHNSON SALIVA EJECTORS
Received Nov 22, 1996 · Event occurred Oct 15, 1996
Report 1618732-1996-00074 · MDR key 52640
Device
Generic name
Mouthpiece, Saliva Ejector
Manufacturer
Johnson & Johnson Medical, Inc.Model number
NACatalog number
2768
Lot number
UNK
Patient
*
Narrative
Additional Manufacturer Narrative
DATE SENT TO FDA: 12/20/96. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER SPECIFIED IN THE COMPLAINT IS NOT A LOT NUMBER ISSUED BY THE MFR. WITHOUT SAMPLES TO EVALUATE THE ALLEGED FAILURE OF THE PRODUCT TO MEET EXPECTED PERFORMANCE CANNOT BE CONFIRMED. CO IS NO LONGER DOING BUSINESS WITH THE MFR OF THE SALIVA EJECTOR. CO IS IN PROCESS OF EVALUATING ANOTHER VENDOR. NO CORRECTIVE ACTION WILL BE TAKNE WITH THE MFR.
Remedial action
- Other