Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1532
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000401
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.
22-FEB-24
5. Location of incident.
Country: CANADA
Prov / State: MANITOBA
6. Date incident was first observed.
22-FEB-24
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.
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 22-Feb-2024, a clinic staff member contacted Elanco regarding a possible adverse reaction and perceived lack of efficacy following application of Clean-Up II Pour-On Insecticide with IGR (Permethrin, Diflubenzuron). On an unknown date the producer applied the product to an unknown number of cows and the cows were also administered fenbendazole.
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
Medical Professional
2. Type of animal affected
Cow / Vache
3. Breed
Unknown
4. Number of animals affected
1
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?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Pruritus
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 22-Feb-2024, the unknown number of cattle, of unknown signalment, with concomitant lice, showed signs of having lice and all the cows were rubbing and had hair loss. A veterinarian has not examined the cows and it has not been confirmed if the cows have lice. The outcome of this case is therefore unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here