Section 7: PERFORMANCE/COMPLAINT ANALYSIS Is there a product history for this device Yes No If “No” please identify equivalent device(s) and relevant performance data 1. a. What is the time period of the data being provided – What are the: Total no. units placed on the market worldwide) b. Total no. of complaints worldwide Total Number of EU Vigilance Reports Please provide: 2. Trended analysis (graphical form) of the data over the stated period of time. Summary table of the individual complaints, with quantity and % total sales Please summarize all global Vigilance issues that fulfil the European Reporting requirements in the following/similar format: 3.
Section 7: PERFORMANCE/COMPLAINT ANALYSIS 1. Is there a product history for this device Yes No If “No” please identify equivalent device(s) and relevant performance data a. What is the time period of the data being provided – b. What are the: Total no. units placed on the market worldwide) Total no. of complaints worldwide Total Number of EU Vigilance Reports 2. Please provide: Trended analysis (graphical form) of the data over the stated period of time. Summary table of the individual complaints, with quantity and % total sales 3. Please summarize all global Vigilance issues that fulfil the European Reporting requirements in the following/similar format:
GRF-25-50a.docx