Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0132

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0052264 (Report 669810)

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.

07-OCT-20

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

16-SEP-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. 11556-143

Product Name: K9advantixII large dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Small Dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-125

Product Name: Advantage II Medium Dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Other (specify)

Spot-on, Collar

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 approximately 01-Dec-2019, a 7 year old, 18 pound, female, Schnauzer (Unspecified)/Shih Tzu crossbred dog, of unknown reproductive status, in unknown condition, with the concomitant medical conditions of fleas, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner.On approximately 25-Aug-2020, the dog was administered 1 tube of Advantage II Medium Dog (11-20 lbs) (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner.On 06-Oct-2020, the dog was given a bath with an unspecified pet shampoo and then was administered a partial tube of K9 Advantix II Large Dog (21-55 lbs) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner. This was extra label use as the product is not intended to be applied as a partial dose.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

cross breed (Schnauzer x Shih Tzu)

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

8.618

kg

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

• Gastrointestinal System
  • Symptom - Anorexia

• Skin
  • Symptom - Hives

• General
  • Symptom - Lethargy
  • Symptom - Hyperthermia

• Gastrointestinal System
  • Symptom - Vomiting

• Skin
  • Symptom - Rash

• General
  • Symptom - Death
  • Symptom - Parasitism

12. How long did the symptoms last?

Persisted until death

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

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 16-Sep-2020, the dog developed a decreased appetite. Approximately 8 hours post application, the dog developed hives and a rash. On 07-Oct-2020, the dog developed lethargy, warm skin, and emesis. The dog was not examined by the veterinarian, no treatments were performed, and the clinical sign and fleas continued. On 08Oct2020, the canine died at home. No necropsy 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 Decrease appetite is not expected as sign was reported prior to the product application. Product has very low allergic potential. However, in individual cases, a hypersensitivity reaction to the product such as hives are possible in animals that are particularly sensitive (as with any substance). Short time to onset. No other possible cause reported. Reported rash is not expected after product use, however, in this case rather associated with current flea infestation. Reported lethargy is unspecific sign may be a consequence of the feeling caused by the applied product. Warm skin is not anticipated with appropriate topical product use. Reported emesis is an unspecific sign and may have many potential causes. However, time to onset is short. Product may have been groomed off of the application site. Death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Other etiologies are more likely. Animal was treated with a too low dose of the product, thus the labelled efficacy of the product cannot be guaranteed. Therefore a lack of efficacy cannot be considered. However, considering very low level of information (no necropsy details), a product connection is remains unassessable.