Description of Event or Problem · 1
THIS IS A VERBATIM REPORT AS RECEIVED BY VALEANT FROM Q-MED. THIS REPORT CONCERNS A PUBLISHED ARTICLE DESCRIBING 7 PATIENTS WITH BACTERIAL CELLULITIS OF THE FACE FOLLOWING TREATMENT WITH AN UNSPECIFIED HA FILLER IN THE NASOLABIAL FOLDS. THEY WERE TREATED IN A UNIVERSITY HOSPITAL FROM 2005 TO 2012. ALL PATIENTS WERE FEMALE AND BETWEEN 34 AND 57 YEAR OLD. THERE WAS NO INFO REGARDING THE PATIENT'S MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR ALLERGIES. TWO PATIENTS HAD PREVIOUSLY RECEIVED DERMAL FILLERS (NOT SPECIFIED WHICH PRODUCTS AND WHICH PATIENTS). ALL PATIENTS HAD BEEN TREATED WITH A HYALURONIC ACID DERMAL FILLER IN THE NASOLABIAL FOLDS BY GENERAL PRACTITIONERS. ALL PTS HAD BEEN TESTED WITH A HYALURONIC ACID DERMAL FILLER IN THE NASOLABIAL FOLDS BY GENERAL PRACTITIONERS. TREATMENT DATES ARE NOT KNOWN. THE PATIENTS WERE NOT ABLE TO GIVE THE EXACT NATURE OR TRADEMARK OF THE HYALURONIC ACID INJECTED. PRODUCT NAME, PRODUCT LOT NUMBER, AMOUNT (ML) INJECTED AND THE INJECTION TECHNIQUE USED ARE UNK. THIS CASE REFERS TO A (B)(6) FEMALE PATIENT. ON AN UNK DATE BETWEEN 2005 AND 2012, THE PATIENTS SUFFERED SEVERE FACIAL BACTERIAL DERMOHYPODERMITIS [DERMO-HYPODERMIS] IN THE NASOLABIAL FOLDS. THE PATIENT WAS TREATED WITH AMOXICILLIN +CLAVULANIC ACID 6G/DAY DURING 8 DAYS. IT WAS REPORTED THAT ONE OF THE PATIENTS REQUIRED HOSPITALIZATION IN THE INTENSIVE CARE UNIT, HOWEVER, IT WAS NOT CLEAR WHICH PT THIS WAS. THE OUTCOME OF THE EVENT WAS REPORTED TO BE RECOVERED. THE MFR'S DEVICE ANALYSIS RESULTS: THE PUBLISHED ARTICLE STATES THAT A HYALURONIC ACID FILLER HAS BEEN USED IN ALL SEVEN CASES, HOWEVER, IT IS NOT CLEAR WHETHER ANY Q-MED PRODUCTS HAVE BEEN USED. PRODUCT TRADEMARK NAMES OR LOT NUMBERS ARE NOT KNOWN. FURTHER ANALYSES OF THE DEVICES COULD THEREFORE NOT BE DONE. FINAL COMMENTS FROM THE MFR: THE PUBLISHED ARTICLE STATES THAT A HYALURONIC ACID FILLER HAS BEEN USED IN ALL SEVEN CASES, HOWEVER, IT IS NOT CLEAR WHETHER ANY Q-MED PRODUCTS HAVE BEEN USED. A CAUSAL RELATION BETWEEN TREATMENT AND IMPLANT SITE INFECTION CANNOT BE EXCLUDED. THE INJECTION PROCEDURE PER SE MAY HAVE CONTRIBUTED TO THE EVENT. THE CONCLUSION OF THE ARTICLE POINTS OUT THE INOCULATION OF GERMS DUE TO THE LACK OF HYGIENE AND FUNDAMENTAL PRECAUTIONS OF CERTAIN PRACTITIONER AND NOT THE CAUSALITY OF THE HYALURONIC ACID ITSELF NO FURTHER INVESTIGATIONS ARE PLANNED. THIS CASE IS LINKED TO (B)(4). FOR REFERENCE PURPOSES ONLY, THE FOLLOWING TRACKING NUMBER HAS BEEN ASSIGNED: (B)(4). THIS CASE WAS RECEIVED BY (B)(4) ON (B)(4) 2013 AND WAS FORWARDED TO VALEANT ON (B)(4) 2013.