Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0136

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0056815 (Report 674663)

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.

03-NOV-20

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

6. Date incident was first observed.

03-NOV-20

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-186

Product Name: Clean-Up II Pour-On

• Active Ingredient(s)
  • DIFLUBENZURON
    • Guarantee/concentration 3 %
  • PERMETHRIN
    • Guarantee/concentration 5 %

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

15

Units: mL

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 17-Oct-2020, a 550 pound bovine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 15 ml of Clean Up II Pour-On (unspecified) (Permethrin-Diflubenzuron) orally by the owner. This is an extra-label exposure (route) to the product as it is labeled for topical application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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 )

249.476

kg

8. Route(s) of exposure

Oral

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

• General
  • Symptom - Death

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

Died

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 approximately 03Nov2020, the calf died. It was unknown if a necropsy examination was performed.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable Off-label use as product was applied orally instead of topically. Death not expected following recommended use of the product as not consistent with the pharm-tox product profile. For Permethrin LD50 in rats following oral uptake is 1300 mg/kg. In this case the treated animal ingested in total 750 mg. However, unknown whether additional ingredients could have caused any serious signs that lead to death. Onset time of 17 days exceptionally long. Signs of Permethrin intoxication usually occur within a few hours after contact. Limited information available on, i.e. health status prior to product application, circumstances of death and whether necropsy was performed. Overall, due to insufficient information, product relation is considered unclassifiable.