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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1847
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000215
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.
29-JAN-245. Location of incident.
Country: CANADA
Prov / State: SASKATCHEWAN
6. Date incident was first observed.
29-JAN-24Product 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
- Active Ingredient(s)
- DIFLUBENZURON
- PERMETHRIN
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 29-Jan-2024, a clinic staff member 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 cattle. On 19-Dec-2023 the producer applied the product to the cows. On 20-Dec-2023 the producer applied the product to the rest of the 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
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
>1 mo <=2 mos / > 1 mois < = 2 mois
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.
Unknown
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 29-Jan-2024, the herd of cattle of unknown signalment, with a history of scratching and lice infestation, were scratching again and had hair loss on their backs and necks. The animal owner complained the cattle had lice. On an unknown date, the cattle were examined by the veterinarian and were found to be free of lice. Hair loss on the neck was still present. On 12-Feb-2024, Elanco received results for trace minerals (samples collected 19 Dec 2023). All values were within normal limits, except for one sample where Cobalt was marginal.
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
Medical Professional
2. Type of animal affected
Cow / Vache
3. Breed
Unknown
4. Number of animals affected
3
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
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Hair loss
- Blood
- Symptom -
- Specify - Copper deficiency
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?
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 29-Jan-2024, the herd of cattle of unknown signalment, with a history of scratching and lice infestation, were scratching again and had hair loss on their backs and necks. The animal owner complained the cattle had lice. On an unknown date, the cattle were examined by the veterinarian and were found to be free of lice. Hair loss on the neck was still present. On 12-Feb-2024, Elanco received results for trace minerals (samples collected 19 Dec 2023). All values were within normal limits, except for one sample where Cobalt was marginal. On 13-Feb-2024, 10 serum samples were obtained from 10 random cattle in the herd (samples taken from different animals than were tested on 19-Dec-2023), and skin scrapings were obtained from 3 groups. No mites were found and 3 out of the 10 samples showed a deficiency in Copper (coded as Trace Element disorder).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
