Get the free www.accessdata.fda.govscriptscdrhMAUDE Adverse Event Report: BECTON, DICKINSON AND C...
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SUBSTANTIALLY EQUIVALENT January 31, 2022, Benton, Dickinson and Company Attention: Jennifer Kara fin Regulatory Affairs Specialist 2350 Hume Drive San Jose, CA 95131 Re: BK210652 Trade/Device Name:
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The www.accessdata.fda.gov/scripts/cdrh/maude/ adverse event report is needed by individuals or organizations who want to report any adverse events related to medical devices. This includes manufacturers, healthcare professionals, patients, caregivers, and other concerned parties. By reporting adverse events, they contribute to the identification and monitoring of potential safety issues with medical devices, helping to improve patient safety.
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The www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude adverse event report is a platform for reporting adverse events related to medical devices to the FDA.
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Manufacturers, importers, device user facilities, and distributors are required to file www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude adverse event reports for medical devices.
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The purpose of www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude adverse event report is to collect information on adverse events related to medical devices for monitoring and safety purposes.
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Information such as device details, patient information, adverse event description, and reporter contact information must be reported on www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude adverse event report.
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