What is a Maude database?
MAUDE data represents reports of adverse events involving medical devices. An on-line search is available which allows you to search the CDRH’s database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE data is current through the end of the previous month.
How often is Maude database updated?
Data Source This API hosts all MAUDE Medical Device Reports and the database is updated weekly with new reports. The API contains Medical Device Reports from as far back as 1991, whereas the FDA’s MAUDE database search tool is limited to reports from the last 10 years.
When was the Maude database created?
1991
The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable reporting system that was created in 1991. It is maintained by a division of the Food and Drug Administration (FDA) and is available for public use under the Freedom of Information Act [3] .
What is a Maude?
1 : a gray and black plaid worn in southern Scotland. 2 : a double fabric or a blanket or shawl with design like that of a maud plaid.
What is MDR FDA?
Mandatory Medical Device Reporting: The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
What does FDA do with the information from user facilities?
What does FDA do with the information from user facilities? A user facility’s reports to FDA of device-related deaths are entered in a database along with the MDR reportable death, serious injury and malfunction reports filed by manufacturers and importers, and the voluntary reports received from other sources.
What is MDR report key?
The Master Event file includes two database key fields: MDR REPORT KEY which identifies unique reports and is important for linking most of the MAUDE files together and EVENT KEY which is an internally-generated field used to identify unique events.
How old was Maude in the show?
47-year-old
The storyline was originally created to win a contest However, after reading an initial script, Lear, the show’s executive producer and creator, decided it needed to be Maude, a 47-year-old woman with an adult daughter and grandson.
What is MDR certification?
This certification verifies that a device meets all regulatory requirements for medical devices, which will soon change under the new Medical Devices Regulation (MDR 2017/745).
Does pharmacovigilance apply to medical devices?
Medical device Pharmacovigilance is the monitoring of safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action.
What kind of data is in MAUDE database?
MAUDE data represents reports of adverse events involving medical devices. The download data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The searchable database data contains the last 10 year’s data.
Who are the mandatory reporters for THE MAUDE database?
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
Who are the Maude manufacturers and user facility device experience?
MAUDE – Manufacturer and User Facility Device Experience. The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
How is Maude data used to evaluate adverse events?
MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term (s) provided by the requester.