COMFORT PLUS¿ PREMIUM SALIVA EJECTORS

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER. DEVICE LOT NUMBER NOT PROVIDED TO MANUFACTURER. REVIEW OF COMPLAINT RECORDS FOR THE LAST FIVE YEARS FOUND NO COMPLAINTS OF ALLERGIC REACTIONS FOR SUSPECTED DEVICE. ADVERSE EVENT CAUSE COULD NOT BE ESTABLISHED DUE TO LACK OF INFORMATION AND DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

DISTRIBUTOR REPORTED THAT A PATIENT HAD A REACTION TO A SALIVA EJECTOR. THE PATIENT'S FACE BROKE OUT.