VOCO CLIP

Description of Event or Problem

INCIDENT DESCRIPTION RECEIVED FROM MHRA WITH USER REPORT (B)(4): "PATIENT HAD TEMPORARY FILLING MATERIAL PLACED AFTER A CROWN PREPARATION. MATERIAL IS CALLED 'CLIP' AND MANUFACTURED BY VOCO FOR DENTAL USE. PATIENT DISCLOSED ALLERGY TO GEL NAMES AND WHEN INGREDIENTS CROSS-MATCHED METHACRYLATE WAS THE COMMONALITY. PATIENT TESTED SMALL AMOUNT OF CLIP AGAINST SKIN AND REDNESS RESULTED TO CONFIRM ALLERGY. WE REPLACED THE TEMPORARY MATERIAL AND NO FURTHER PROBLEMS. PATIENT HAD TAKEN AN ANTIHISTAMINE AND IBUPROFEN AND ENCOURAGED SALTED MOUTHWASHES FOR SYMPTOMATIC RELIEF... WHERE WAS THE MEDICINE OBTAINED: "DENTAL SOURCE VOCO" DO YOU THINK THIS REACTION OCCURRED AS A RESULT OF A MISTAKE MADE IN THE PRESCRIPTION, DOSING, DISPENSING OR ADMINISTRATION OF THE MEDICATION?: "NO" REASON: DENTAL CARE. REACTION: REDNESS. REACTION: MOUTH SWELLING..."