Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7144

2. Registrant Information.

Registrant Reference Number: 160133789

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.

07-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-AUG-16

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. 31368      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II With Smart Shield Flea Control for Cats and Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE

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PMRA Registration No. 31986      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution for Dogs Between 11 and 25 kg

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

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 August 23, 2016 the owner inappropriately split the vial of Zodiac spot on for cats between 2 cats and applied the Zodiac InfeStop onto the dog.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

6.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite
  • Symptom - Weight loss
  • Symptom - Diarrhea

• 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 August 26, 2016 the cat developed lethargy, inappetence, and weight loss. On September 4, 2016 the cat developed diarrhea and died. The owner did not take the cat into the clinic due to the holiday weekend. On September 7, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated s-methoprene is an insect growth regulator (IGR). The APSS veterinarian stated if ingested there could be hypersalivation and nausea. The APSS stated a necropsy was not possible as the body would not be viable as the owner had already buried the cat's body.

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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 considered to have a doubtful likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

17.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Hives

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 August 26, 2016 the dog developed symtoms. The owner contacted the regular veterinarian who recommended giving benadryl at home. On August 27, 2016 the owner gave the dog diphenhydramine (2 tablets twice daily (BID) 25 mg each). On September 7, 2016 the owner contacted the Animal Product Safety Service (APSS). The owner stated that the dog has had rashes before from flea/tick products, treated with an unknown pink pill from veterinarian, unknown when it was given most recently. The APSS veterinarian stated would only expect dermal irritation if anything. The APSS assistant recommended taking the dog to the veterinarian (for further exam as we don't believe the product is going to be the cause of his signs) and having the veterinarian call for information.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

Signs are expected to be mild and self-limiting.