Serious injury

Serious injury means an injury or illness that:
(1) Is life-threatening,
(2) Results in permanent impairment of a body function or permanent damage to a body structure, or
(3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.
(x) User facility report number means the number that uniquely identifies each report submitted by a user facility to manufacturers and to us. This number consists of the following three parts:
(1) The user facility's 10-digit Centers for Medicare and Medicaid Services (CMS) number (if the CMS number has fewer than 10 digits, fill the remaining spaces with zeros);
(2) The four-digit calendar year in which the report is submitted; and
(3) The four-digit sequence number of the reports submitted for the year, starting with 0001. (For example, a complete user facility report number will appear as follows: 1234560000–2011–0001. If a user facility has more than one CMS number, it must select one that will be used for all of its MDR reports. If a user facility has no CMS number, it should use all zeros in the appropriate space in its initial report (e.g., 0000000000–2011–0001). We will assign a number for future use and send that number to the user facility. This number is used in our record of the initial report, in subsequent reports, and in any correspondence with the user facility. If a facility has multiple sites, the primary site may submit reports for all sites and use one reporting number for all sites if the primary site provides the name, address, and CMS number for each respective site.)


21 CFR § 803.3

Scoping language

Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute . Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:

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