Description:
This Vigilance and Recall Search Report provides a clear, audit-ready record of how we search public vigilance and recall databases to identify clinical risks. It covers device problems and patient problems linked to the subject device, equivalent device, and similar devices, supporting Safety & Performance (S&P) and S&P acceptance criteria (S&P AC) decisions.

• Confirm the search follows the approved protocol and document any deviations with a justified impact assessment.
• Record the responsible person and the implementation date for every database search.
• Define and justify the search period (start date and end date) to ensure evidence is current and relevant.
• Search predefined vigilance and recall databases (e.g., FDA MAUDE, FDA Medical Device Recalls, ANSM, BfArM, MHRA, Swissmedic, DAEN, SARA, Canadian Recalls and Safety Alerts) and justify why each source is relevant to your device and markets.
• Apply a consistent search limitation strategy when filters differ between databases (e.g., date, language, device category).
• Capture reproducible search queries (manufacturer name, brand name, product code, key terms, date filters).
• Screen each record against defined inclusion/exclusion criteria, and document the rationale for every exclusion.
• Summarise clinical risks as device problems and patient problems for subject/equivalent/similar devices.
• Consolidate results into a structured clinical risk summary by device category.
• Document limitations (e.g., restricted filtering, missing fields, language constraints) and explain how they could influence results.

Use this vigilance and recall search report when you need traceable evidence of market signals such as complaints, adverse events, field safety actions, and recalls. It supports stronger clinical risk assessment, improves consistency during CER updates, and helps demonstrate ongoing monitoring for post-market activities.

At Lexqara, we help you integrate vigilance outputs into clinical documentation and your PMS system. We align the search protocol, screening approach, and risk summaries so your process stays consistent and inspection-ready. Explore our Resource Center [https://lexqara.com/resource-center/] and Post-Market Surveillance [https://lexqara.com/service/post-market-surveillance/]. For institutional context, use FDA MAUDE [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm]. Download the template and request a short gap assessment of your vigilance/recall process.