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MDR Adverse Event Codes | FDA

    https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes
    The FDA MDR adverse event codes are divided into the following seven categories: Note:Certain codes may be referred to by various names. For example, “device codes” refers to Medical Device Problem and Medical Device Component, “patient codes” refers to the two Health Effect sets, and “evaluation … See more

Coding Resources for Medical Device Reports | FDA

    https://www.fda.gov/medical-devices/mdr-adverse-event-codes/coding-resources-medical-device-reports
    Current MDR Adverse Event Codes. The FDA MDR adverse event codes are divided into seven code types. The list below contains a link to the hierarchy for each …

Terminologies for Categorized Adverse Event Reporting …

    https://www.imdrf.org/documents/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes
    Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER): Medical Device Parts and Component Terms and Codes xlsx (28.29 KB) IMDRF …

Medical Device Reporting (MDR): How to Report Medical …

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
    Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 …

How to Code an MDR Adverse Event Report | FDA

    https://www.fda.gov/medical-devices/mdr-adverse-event-codes/how-code-mdr-adverse-event-report
    For each code type, reporters should follow these steps: Click the + button below the name of the code type. A dialog will appear. If you know the FDA code …

2023 ICD-10-CM Codes Y70-Y82: Medical devices …

    https://www.icd10data.com/ICD10CM/Codes/V00-Y99/Y70-Y82
    Medical devices associated with adverse incidents in diagnostic and therapeutic use Y70-Y82 ... When a type 2 excludes note appears under a code it is acceptable to use both …

Coding Corner: Successful Coding of Device Failure

    https://www.fortherecordmag.com/archives/0219p26.shtml
    For The Record. Vol. 31 No. 2 P. 26. Recently, word of a legal case in which the attorney cited the use of the code for “device failure” to support suing the device manufacturer …

Medical Device Regulation codes - Medical Device HQ

    https://medicaldevicehq.com/articles/medical-device-regulation-codes/
    The Medical Device Regulation codes, or MDR codes for short, specify what the notified bodies are designated for and thereby stipulate what category of devices the …

Annex A: Medical Device Problem

    https://www.imdrf.org/working-groups/adverse-event-terminology/annex-medical-device-problem
    A010202 - Loss of Osseointegration. Problem associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading …

2023 ICD-10-CM Diagnosis Code T85.698A

    https://www.icd10data.com/ICD10CM/Codes/S00-T88/T80-T88/T85-/T85.698A
    ICD 10 code for Other mechanical complication of other specified internal prosthetic devices, implants and grafts, initial encounter. Get free rules, notes, …



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