STRAUMANN EMDOGAIN

Description of Event or Problem

ACCORDING TO THE INFORMATION PROVIDED ON (B)(6) 2013 THE CUSTOMER REPORTS THAT THEY HAD AN ISSUE WITH A PATIENT RECENTLY TREATED WITH EMDOGAIN. THE PATIENT DEVELOPED A SORT OF CUTANEOUS REACTION WHOSE ORIGIN CANNOT BE DETECTED. THE CLINICIAN REQUESTED A TECHNICAL SHEET OF EMDOGAIN REPORTING TECHNICAL SPECIFICATIONS OF THE PRODUCT, STERILIZATION ETC. BASED ON THE TELEPHONE CONVERSATION BETWEEN STIT COMPLAINT HANDLING AND THE CUSTOMER ON (B)(6) 2013 ADDITIONAL INFORMATION WAS REQUESTED. THE CUSTOMER USED ARTICLE 075.114 EMDOGAIN 0.3ML MULTIPACK LOT NUMBER EA593. THE SURGERY USING EMDOGAIN AND PREFGEL WAS CARRIED OUT IN (B)(6) ON (B)(6) 2012. THE EVENT DATE IS (B)(6) 2012. THE CUSTOMER REPORTS THERE WAS SWELLING AND INFLAMMATION. WE PRESUME THAT THE PREFGEL USED ALSO CAME FROM THE ARTICLE 075.114 LOT EA593. THE CLINICIAN PROVIDED ADDITIONAL INFORMATION ON (B)(6) 2013. THE CLINICIAN REPORTS THAT THE PATIENT HAS A BULGE. NO TREATMENT HAS BEEN ADMINISTERED TO THE PATIENT AS THE CLINICIAN HAS TO INVESTIGATE THE REASONS OF THE REACTION.

Additional Manufacturer Narrative

MATERIAL SAFETY DATA SHEET WAS SENT TO CUSTOMER AS REQUESTED. THE RISK MANAGEMENT REPORT "RISK MGMT REPORT_EMDOGAIN-PREFGEL_V3" HAS IDENTIFIED THAT THE USE OF EMDOGAIN IN PATIENTS WITH COMPROMISED HEALTH CONDITIONS OR IN PATIENTS PRE-DISPOSED TO ALLERGIC REACTIONS MIGHT RESULT IN A BODY REACTION (E.G. ALLERGIC REACTION) AND IS REFLECTED IN THE EU IFU LABELLING 70016 / 701354. THIS LABELLING STATES THAT THE "STRAUMANN PRODUCT MUST BE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE PROVIDED BY THE MANUFACTURER. IT IS THE PRACTIONER'S RESPONSIBILITY TO USE THE DEVICE IN ACCORDANCE WITH THESE INSTRUCTIONS FOR USE AND TO DETERMINE IF THE DEVICE FITS TO THE INDIVIDUAL PATIENT SITUATION." THE MANUFACTURER REVIEWED MANUFACTURING BATCH RECORDS FOR 075.114 LOT EA593 WHICH CONTAINS EMDOGAIN BATCH CH476B AND PREFGEL BATCH AE811. ALL PRODUCTS WERE RELEASED ACCORDING TO SPECIFICATIONS. REVIEW OF THE COMPLAINTS DATABASE ALSO CONFIRMED THAT NO FURTHER COMPLAINTS HAVE BEEN REPORTED WITH THIS ARTICLE AND LOT NUMBER.