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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2278
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000680
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 1919 Minnesota Court, Suite 401
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5N 0C9
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
18-MAR-245. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
Unknown
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)PMRA Registration No. 25674 PMRA Submission No. EPA Registration No.
Product Name: Cylence Pour On Insecticide
- Active Ingredient(s)
- CYFLUTHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
On 18Mar2024, a producer contacted Elanco and unintentionaly reported an adverse reaction with CyLence Pour on Insecticide (Cyfluthrin). The following was reported: On an unknown date in Mar2023, the producer applied an unknown amount CyLence Pour on Insecticide (Cyfluthrin) to a herd of 14 beef cow/calves. On an unknown date, 3 weeks after the first application, the producer once again applied an unknown amount of CyLence Pour on Insecticide (Cyfluthrin) to the herd of 14 beef cow/calves. On an unknown date in Oct2023, the producer once again applied an unknown amount CyLence Pour on Insecticide (Cyfluthrin) to the herd of 14 beef cow/calves. On 27Feb2024 the producer applied an unknown amount CyLence Pour on Insecticide (Cyfluthrin) to one cow (see domestic animal 2 subform). On 16Mar2024 the producer applied an unknown amount CyLence Pour on Insecticide (Cyfluthrin) to another cow. On 17Mar2024 the producer applied an unknown amount CyLence Pour on Insecticide (Cyfluthrin) to two more cows (see domestic animal 3 subform).To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cow / Vache
3. Breed
Unknown
4. Number of animals affected
11
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Skin
- Symptom - Hair loss
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On an unknown date approximately 4 weeks after the initial application of Cylence, the 11 cow/ calves of unknown age, weight, and breed, with lice, developed hair loss on their shoulders and neck. The hair loss was not at the application site.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cow / Vache
3. Breed
Unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Skin
- Symptom - Hair loss
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On an unknown date approximately 4 weeks after the initial application of Cylence, the female cow of unknown age, weight, and breed, with lice, developed hair loss on their shoulders and neck. The hair loss was not at the application site. On 06Mar2024 the cow developed hair loss at the shoulders and neck. The hair loss was not at the application site.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cow / Vache
3. Breed
Unknown
4. Number of animals affected
2
5. Sex
Female
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Hair loss
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On an unknown date approximately 4 weeks after the initial application of Cylence, the 2 female cows of unknown age, weight, and breed, with lice, developed hair loss on their shoulders and neck. The hair loss was not at the application site. On 18Mar2024 both cows had hair loss on the shoulders and neck. The hair loss was not at the application site.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
