Example Reported LLT Selected Pharmacist stole medications from the pharmacy and sold them to others for Drug diversion recreational use Drug diversion A person put a sedative into the patient’s drink Inadvertent exposure to drug Transmission of Infectious Agent via Product If a report of transmission of an infectious agent via a product is received, select a term for the transmission. 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). Example Reported LLT Selected Transmission of an infectious agent via Patient received a nasal spray product and product later developed a severe nasal infection with Cultures of Burkholderia cepacia. Product contamination bacterial unopened containers of the nasal spray grew B. cepacia Burkholderia cepacia infection Transfusion-transmitted infectious disease Patient received a blood transfusion and developed Hepatitis C Hepatitis C Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via a product but this could be implied by other data within the report. In this instance, select LLT Suspected transmission of an infectious agent via product. Overdose, Toxicity and Poisoning Accidental overdose terms are grouped under HLT Product administration errors and issues; other overdose terms are grouped under HLT Overdoses NEC. Toxicity and poisoning terms are grouped under HLT Poisoning and toxicity. For more information, refer to the MedDRA Introductory Guide.
Example Reported LLT Selected Pharmacist stole medications from the pharmacy and sold them to others for recreational use Drug diversion A person put a sedative into the patient’s drink Drug diversion Inadvertent exposure to drug Transmission of Infectious Agent via Product If a report of transmission of an infectious agent via a product is received, select a term for the transmission. 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). 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 product Product contamination bacterial Burkholderia cepacia infection Patient received a blood transfusion and developed Hepatitis C Transfusion-transmitted infectious disease Hepatitis C Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via a product but this could be implied by other data within the report. In this instance, select LLT Suspected transmission of an infectious agent via product. Overdose, Toxicity and Poisoning Accidental overdose terms are grouped under HLT Product administration errors and issues; other overdose terms are grouped under HLT Overdoses NEC. Toxicity and poisoning terms are grouped under HLT Poisoning and toxicity. For more information, refer to the MedDRA Introductory Guide.
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