
Get the free Pediatric Level I or IITrauma Program Checklist/Attestation
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Pediatric Level I or II Trauma Program Checklist/Attestation To reduce the morbidity and mortality of trauma patients in Louisiana, the LEARN Board authorized an evaluation process which recognizes
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What is a pediatric level I or?
A pediatric level I or is a form used to report adverse events or problems related to medical devices specifically for pediatric patients.
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Manufacturers, importers, and device user facilities are required to file pediatric level I or for medical devices used on pediatric patients.
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Pediatric level I or can be filled out electronically through the FDA's MedWatch website or by submitting a paper form to the FDA.
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The purpose of pediatric level I or is to monitor and track adverse events or problems related to medical devices used on pediatric patients in order to improve device safety.
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Pediatric level I or must include information on the patient, the device, the adverse event or problem, and the reporter.
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