If the infection is identified, select a second term for the specific infection; if appropriate, a product quality issue term can also be selected (See Section 3.28). Note also that this section number has changed from 3.16 to 3.17. Also in this section, an additional LLT was added to the Example table: Example Reported LLT Selected Patient received a nasal spray product and later developed a severe nasal Transmission of an infectious agent via a infection with Burkholderia cepacia. medicinal product Cultures of unopened containers of the Burkholderia cepacia infection nasal spray grew B. cepacia As follows (LLT Product contamination bacterial was Reported LLT Selected Patient received a nasal spray product Transmission of an infectious agent via a and later developed a severe nasal medicinal product infection with Burkholderia cepacia. Product contamination bacterial Cultures of unopened containers of the Burkholderia cepacia infection nasal spray grew B. cepacia Finally, the last paragraph in this section: Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via medicinal product but this could be implied by other data within the case. In this instance, select LLT Suspected transmission of an infectious agent via a medicinal product. The same LLT should be used in the E2B field for the sender’s diagnosis (B.5.3). Was changed as follows (note substitution of the word for and “report” “case” deletion of the last sentence): Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via medicinal product but this could be implied by other data within the report. In this instance, select LLT Suspected transmission of an infectious agent via a medicinal product.
If the infection is identified, select a second term for the specific infection; if appropriate, a product quality issue term can also be selected (See Section 3.28). Note also that this section number has changed from 3.16 to 3.17. Also in this section, an additional LLT was added to the Example table: Example Reported LLT Selected Patient received a nasal spray product and later developed a severe nasal infection with Burkholderia cepacia. Cultures of unopened containers of the nasal spray grew B. cepacia Transmission of an infectious agent via a medicinal product Burkholderia cepacia infection As follows (LLT Product contamination bacterial was Reported LLT Selected Patient received a nasal spray product and later developed a severe nasal infection with Burkholderia cepacia. Cultures of unopened containers of the nasal spray grew B. cepacia Transmission of an infectious agent via a medicinal product Product contamination bacterial Burkholderia cepacia infection Finally, the last paragraph in this section: Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via medicinal product but this could be implied by other data within the case. In this instance, select LLT Suspected transmission of an infectious agent via a medicinal product. The same LLT should be used in the E2B field for the sender’s diagnosis (B.5.3). Was changed as follows (note substitution of the word “report” for “case” and deletion of the last sentence): Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via medicinal product but this could be implied by other data within the report. In this instance, select LLT Suspected transmission of an infectious agent via a medicinal product.
termselptc_r4.5soc_mar2013.docx