Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1531
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000367
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.
21-FEB-24
5. Location of incident.
Country: CANADA
Prov / State: SASKATCHEWAN
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. 33691
PMRA Submission No.
EPA Registration No. 11556-186
Product Name: Clean Up II
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 21-Feb-2024, a producer contacted Elanco regarding a possible adverse reaction and perceived lack of efficacy to Clean-Up II Pour-On Insecticide with IGR (US-labeled) (Permethrin, Diflubenzuron) in a herd of 120 cattle. On an unknown date in Dec-2023, the producer applied the product to the entire herd.
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
38
5. Sex
Female
6. Age (provide a range if necessary )
1.8
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
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 following application, 38 heifers that were 1.8 years old and weighed between 591 kg and 818.2 kg, with concomitant scratching, stopped scratching. On an unknown date in Feb-2024, the heifers started to scratch again. The producer feels the product did not work due to the recurrence of the scratching. It has not been confirmed whether or not the cattle have lice. Update On 25-Feb-2024 an Elanco veterinarian spoke with the producer who reported that, on an unknown date, he had found a mangy looking coyote in the pen with the cows. It was suggested that another etiology, other than lice, may be contributing to the reported signs. The producer declined a veterinary exam to confirm the cause of the signs therefore the outcome of this case is unknown.
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
Male
6. Age (provide a range if necessary )
1.8
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
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 post application, 2 bulls that were 1.8 years old and weighed between 591 kg and 818.2 kg, with concomitant scratching, stopped scratching. On an unknown date in Feb-2024, the 2 bulls started to scratch again. The producer feels the product did not work due to the recurrence of scratching. It has not been confirmed whether or not the cattle have lice. Update On 25-Feb-2024 an Elanco veterinarian spoke with the producer who reported that, on an unknown date, he had found a mangy looking coyote in the pen with the cows. It was suggested that another etiology, other than lice, may be contributing to the reported signs. The producer declined a veterinary exam to confirm the cause of the signs therefore the outcome of this case is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here