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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5414

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0040562 (Report 657462)

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.

10-AUG-20

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

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.       PMRA Submission No.       EPA Registration No. 11556-144

Product Name: K9advantixII extra large dog

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

7. b) Type of formulation.

Other (specify)

spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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 10-Aug-2020 a 14 year 10 month old 85 pound neutered female Dobermann dog, in unknown condition with concomitant medical conditions of fleas and arthritis, was administered 1 tube of K9 Advantix II Extra Large Dog via the topical route by the animal owner. The dog was also receiving an unknown dose of Gabapentin orally.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Dobermann

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

38.555

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Respiratory System
    • Symptom - Coughing
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
    • Symptom - Death

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

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

Two hours later, the dog began hypersalivating and coughing, then started vomiting up thick foam. The dog became very lethargic. On 11 Aug 2020, the dog died. A necropsy was performed with unknown results.


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 Reported coughing is not expected after product application. Hypersalivation and vomiting thick foam are unspecific signs. No oral product uptake reported. Signs in this case may be associated with concomitant oral administration of another product. Lethargy likely associated with other reported signs. Later reported death is not expected after product application as inconsistent with pharmaco-toxicological product profile. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Other causes should be considered in this geriatric dog. No necropsy was performed. Considering all aspects, a product connection is unassessable.