Recall report

Name: Recall report
Creator: Federal Institute for Drugs and Medical Devices
Keywords: actions,databases,field-safety-corrective-action,forms,fsca,manufacturers,measures,recalls,reporting,safety

Information

Original link

Type

Miscellaneous

Regulated products

Medical Devices

Topics

Reports And Corrective Actions

Description

Field Safety Corrective Actions (FSCA)
Measures taken by manufacturers

Organization

Federal Institute for Drugs and Medical Devices (BfArM) 🇩🇪

Country / Region

Germany

License

Other (Public Domain)

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11 Main files

Form

Updated on November 26, 2023

pdf (1.0MB)

URL: https://www.bfarm.de/SharedDocs/Formulare/EN/MedicalDevices/fsca_reports.pdf?__blob=publicationFile
Permalink: https://data.openrid.co/en/datasets/r/b7e3a4ee-8d74-40b4-8dae-5877d606fad2
MIME Type: application/pdf

Created on: November 26, 2023
Modified on: November 26, 2023

Size: 1.0MB

Notes

Updated on November 26, 2023

pdf (225.0KB)

URL: https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/Hinweise-Meldeformular_en.pdf?__blob=publicationFile
Permalink: https://data.openrid.co/en/datasets/r/7775deb8-5ba4-416d-9fd8-7657b97cfb7e
MIME Type: application/pdf

Created on: November 26, 2023
Modified on: November 26, 2023

Size: 225.0KB

XSDs for direct reporting from manufacturer databases into XML

Updated on November 26, 2023

zip (8.0KB)

URL: https://www.bfarm.de/SharedDocs/Formulare/EN/MedicalDevices/fsca-reports-xsd.zip?__blob=publicationFile
Permalink: https://data.openrid.co/en/datasets/r/90c867f4-dffb-4f3d-801c-b9f49c982a3b
MIME Type: application/zip

Created on: November 26, 2023
Modified on: November 26, 2023

Size: 8.0KB

Notes on XSD use

Updated on November 26, 2023

pdf (99.0KB)

URL: https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/Hinweise_XSD.pdf?__blob=publicationFile
Permalink: https://data.openrid.co/en/datasets/r/4c2c0aae-b9af-45df-86f2-8eb99a95b2d9
MIME Type: application/pdf

Created on: November 26, 2023
Modified on: November 26, 2023

Size: 99.0KB

Recall report

Updated on November 26, 2023

html

URL: https://www.bfarm.de/EN/Medical-devices/Applications-and-reports/Recall-report/_node.html
Permalink: https://data.openrid.co/en/datasets/r/95cb6daf-b7ed-4877-b7e9-a865fa7265db
MIME Type: text/html

Created on: November 26, 2023
Modified on: November 26, 2023

Field Safety Corrective Actions (FSCA)
Measures taken by manufacturers

Formular

Updated on November 26, 2023

pdf (1.0MB)

URL: https://www.bfarm.de/SharedDocs/Formulare/DE/Medizinprodukte/Meldeformular_Rueckrufe.pdf?__blob=publicationFile
Permalink: https://data.openrid.co/en/datasets/r/39cb28e7-1d26-480c-8c33-8bf7de0c0e08
MIME Type: application/pdf

Created on: November 26, 2023
Modified on: November 26, 2023

Size: 1.0MB

See the 11 main files

Recall report

Information

Type

Regulated products

Topics

Description

Tags

Organization

Country / Region

License

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