Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1528
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000305
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.
13-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 13-Feb-2024, a veterinarian contacted Elanco regarding a possible adverse reaction to Clean-Up II Pour-On Insecticide with IGR (US-labeled) (Permethrin, Diflubenzuron) in 44 cows. On an unknown date in Dec-2023, the producer applied the product to the cows.
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
Beef cattle
4. Number of animals affected
44
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
- Symptom - Pruritus
- General
- Symptom - Abnormal behaviour
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
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 post application, the 44, intact, female, Beef Cattle, ranging in age from 0.8 years old to 10 years old, and ranging in weight from 318.3 kg to 818.2 kg, with concomitant lice, would not stop running (Hyperactivity), were scratching, and had excessive hair loss. It is unknown if the hair loss is at the application site. The producer attributed events to the lice. UPDATE 01Apr2024. On 26Mar2024 the veterinarian examined 2 cows and found sucking lice on one of the cows.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here