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MAN: Surname: Forename:AFFIX LABEL DOB:CUT EMERGENCY DEPARTMENT Pediatric PROCEDURAL SEDATION CHECKLIST Type of procedure BEFORE PROCEDUREPreProcedure assessmentPreparation SOAPMETIMEOUTRequired staff
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Serious adverse events (SAEs) are any undesirable experiences associated with the use of a medical product that results in death, hospitalization, disability, or a significant medical event.
Sponsors of clinical trials, healthcare providers, and sometimes the manufacturers of medical products are required to file reports of serious adverse events.
To fill out a serious adverse event report, one should collect all relevant details including patient information, event description, outcome, and any actions taken. Use the standardized forms provided by regulatory authorities.
The purpose of reporting serious adverse events is to monitor the safety of medical products and to improve risk management by providing data to regulatory agencies.
Information to be reported includes the patient's demographics, details of the event, relation to the product, outcome, and any medical interventions that were conducted.
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