VENTROFIL SUTURE SET-STEELWIRE 1X90CM 2X
Received Apr 25, 2019
Report 3003639970-2019-00388 · MDR key 8552715
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Not reported
- Unspecified Infection
- Patient Problem/Medical Problem
- Unspecified Infection
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS AVAILABLE THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE COMPLAINT HISTORY RECORD, THERE ARE NO PREVIOUS COMPLAINTS FOR VENTROFIL PRODUCT IN THE LAST FIVE YEARS. FINAL CONCLUSION: WITHOUT SAMPLES OR MORE INFORMATION WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS ARE NEEDED.
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. WHEN ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE PATIENT HAS INFECTION AND TISSUE REACTION. THE REPORTER INDICATED THAT THEY ARE HAVING PROBLEMS WITH VENTROFIL STATING THE SUTURE CAUSES INFECTION AND A REACTION IN THE TISSUES RIGHT AWAY, 3-4 DAYS AFTER IMPLANTATION. THE REPORTER STATES THEY USE AN ANTISEPTIC SUBSTANCE TO PROTECT THE POLYETHYLENE PLATE AREA, BUT HAVE ALSO FOUND REACTIONS IN THIS AREA ANYWAY. NO OTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.