SCHEIN COVER FILM

Description of Event or Problem

A DENTAL OFFICE REPORTED THAT A PATIENT HAD ALLEGED EXPERIENCING A REACTION WITH SYMPTOMS OF A RASH, SWELLING, AND SEVERE PAIN AFTER HAVING COME IN CONTACT WITH SURFACES IN THE OFFICE WHICH HAD BEEN COVERED WITH A SHEET OF SCHEIN COVER FILM OR CLEANED WITH CAVIWIPES AND CAVICIDE.

Additional Manufacturer Narrative

SPECIFIC INFORMATION WITH REGARD TO THE PATIENT'S GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. NO LOT NUMBER OR EXPIRATION DATE WAS PROVIDED. IT WAS REPORTED THAT THE PATIENT HAD SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM ON TWO (2) SEPARATE OCCASIONS. THE PATIENT HAD RETURNED TO THE OFFICE ON (B)(6) 2013 AND ALLEGED THAT A SECOND REACTION HAD OCCURRED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR TREATMENT. THE PATIENT HAS NOT CONTACTED THE OFFICE WITH ANY FURTHER INFORMATION; THEREFORE, THE ROOT CAUSE OF THE REACTION AND THE PATIENT'S HEALTH STATUS REMAINS UNKNOWN. METREX HAS REQUESTED THAT THE COMPLAINANT REPORT ANY NEW INFORMATION RECEIVED WITH REGARD TO THIS PATIENT. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.