Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-0283
2. Registrant Information.
Registrant Reference Number: 35277
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
19-JAN-21
5. Location of incident.
Country: CANADA
Prov / State: MANITOBA
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.
Product Name: Clean Up II
- Active Ingredient(s)
- DIFLUBENZURON
- Guarantee/concentration 3 %
- PERMETHRIN
- Guarantee/concentration 5 %
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 31-Dec-2020, half of a mixed herd of cattle that were scratching was administered an unknown dose of Clean Up II (please note the product is Clean Up II and not Cylence), by Animal owner. The product was used according to label (unknown, unknown dose).
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
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 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Skin
- Symptom - Itchy skin
- Symptom - Lesion
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 01 Jan 2021 the remaining members of the herd were treated.
On 15 Jan 2021 the animal owner reported the animals were still itchy and had developed red sores. The veterinarian recommended monitoring. The outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here