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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0955

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2021-US0001975 (Report 683929)

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.

21-JAN-21

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

31-DEC-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-142

Product Name: K9advantixII medium 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.

1

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 14-Dec-2020, a 13 year old, 15 pound, neutered, female, Pug canine, in unknown condition, with the concomitant medical condition of generalized lipomas, was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.

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

Pug

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

6.804

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Specify - multiple
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

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 31 Dec 2020, the dog began vocalizing. On 14 Jan 2021, the dog had the product reapplied and the dog began having multiple seizures lasting approximately 10 seconds each. On 16 Jan 2021, the dog was bathed in a liquid dish detergent. The clinical signs continued. On 20 Jan 2021, the dog began vomiting. On 21 Jan 2021, the dog was anorexic. The dog was not examined by a veterinarian and the clinical signs continued. Follow up received on 25th Jan 2021: On 31 Dec 2020, the dog began vocalizing. On 14 Jan 2021, the dog had the product reapplied and the dog began having multiple seizures lasting approximately 10 seconds each. On 16 Jan 2021, the dog was bathed in a liquid dish detergent. The clinical signs continued. On 20 Jan 2021, the dog began vomiting. On 21 Jan 2021, the dog was anorexic. The dog was not examined by a veterinarian and the clinical signs continued. Follow up received on 28th Jan 2021: On 25 Jan 2021, the dog was examined by a veterinarian and blood work performed was within normal limits. The dog was started on an uspecified oral anticonvulsant medication. On 26 Jan 2021, the dog died. No necropsy was performed. No more information is expected. This case is closed.


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 vocalisation is very unspecific and may have many other numerous causes. Although product (containing a type I pyrethroid) may cause mild transient neurological signs, however reported seizures are not expected following product use. Secondly, dermal absorption is minimal. Other causes should be considered, e.g. idiopathic epilepsy, trauma and neoplasm. Previous applications were tolerated well, without neurological signs. Although time to onset is consistent, convulsion may rather be coincidental. Vomiting unspecific and may have many potential causes. Neither oral exposure nor signs suggestive of it (e.g. hypersalivation) were reported. Time to onset is long. Other causes should be considered. Anorexia in this case may be associated with the reported vomiting. Further reported death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Considering all aspect, a product connection is unassessable.