Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0771

2. Registrant Information.

Registrant Reference Number: 180197622

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

26-NOV-18

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

18-SEP-18

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. 2724-803-270

Product Name: Adams Flea And Tick Spray For Dogs And Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .1 %
  • ETOFENPROX
    • Guarantee/concentration .25 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .75 %

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7. b) Type of formulation.

Liquid

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 September 18, 2018, the regular veterinarian applied a large quantity of this product to the dog to treat a condition.

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

Australian Kelpie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

60.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

• General
  • Symptom - Death
  • Symptom - Parasitism
  • Specify - heartworm

12. How long did the symptoms last?

Persisted until death

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 September 17, 2018, the dog developed lethargy. On the morning of September 18, 2018, the dog developed anorexia and his lethargy became severe. That late afternoon, the owner took the dog to the regular veterinarian for evaluation. The regular veterinarian heavily saturated the dog with the product to treat for fleas. The regular veterinarian then did a diagnostic evaluation (blood work and fecal). The dog was positive for heart worm disease. That night, the dog developed tremors (the owner thought initially that the dog was asleep and just moving his legs while dreaming; the owner is not sure if it was tremors or seizures). An hour later on September 18, 2018, the dog passed away. On September 19, 2018, the owner submitted the dog's body for a necropsy. Upon necropsy, 4 heart worms were found. Per the owner, no definitive cause of death was identified and the dog was cremated. The remaining samples were sent to another diagnostic lab for secondary testing and evaluation for etofenprox. No tissue levels were found in the liver (other organs were not available for testing at this point). On November 26, 2018, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that etofenprox is in the pyrethroid family, although it is structurally different than other pyrethroids and that this insecticide is safe to use on dogs as a topical agent to treat fleas. The APSS veterinarian continued by stating that trembling and tremors can also be seen, whereas seizure activity rarely occurs. The APSS veterinarian discussed with the owner that levels of etofenprox are expected to peak within 3 hours of application and that there is systemic absorption and redistribution with some storage in the liver. The APSS veterinarian also stated that with heart worm disease, there is turbulent blood flow and blood vessels grow abnormally, so a possible clot dislodgement contributing to death after the stressful event such as a veterinary visit could have been seen. The owner expressed concern about the organ samples not being from her dog and wanted to know where she could have DNA testing done. The APSS veterinarian recommended the owner reach out to MMI Genomics or possibly the University of Missouri.

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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

Veterinary staff did not check for fleas, but heavily saturated the dog in the product.