Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6652

2. Registrant Information.

Registrant Reference Number: 170176580

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.

10-OCT-17

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

29-SEP-17

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).

Between September 25, 2017 and September 27, 2017 the owner sprayed the two cats with the product to treat a condition.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

2.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Listless

• Gastrointestinal System
  • Symptom - Anorexia

• Respiratory System
  • Symptom - Other
  • Specify - Upper Respiratory Infection

• General
  • Symptom - Vocalizing
  • Symptom - Death

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 September 29, 2017, the cat developed listlessness, anorexia, and an upper respiratory infection, on October 8, 2017, the cat developed vocalization, and on October 9, 2017, the cat passed away. On October 10, 2017, the owner contacted the Animal Product Safety Service (APSS), whose veterinarian stated that etofenprox is in the pyrethroid family, and is safe to use on cats and dogs as a topical agent to treat fleas. The APSS veterinarian stated that oral exposures often results in hypersalivation, nausea, and vomiting because of the taste and that some animals will hypersalivate just from the odor of the product. The APSS technician recommended the owner call their veterinarian to view the body to determine if it is still viable for a necropsy and call back with questions.

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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

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A necropsy was unavailable as the cat had already been buried.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Siamese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Listless

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Death

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 September 29, 2017 the cat developed symtoms. On October 2, 2017 the cat passed away. On October 10, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that etofenprox is in the pyrethroid family, and is safe to use on cats and dogs as a topical agent to treat fleas. The APSS veterinarian stated that oral exposures often result in hypersalivation, nausea, and vomiting because of the taste and that some animals will hypersalivate just from the odor of the product. The APSS technician recommended the owner call back with questions.

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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

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. A necropsy was unavailable as the cat had already been buried.