Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0152

2. Registrant Information.

Registrant Reference Number: 160159730

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-OCT-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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)

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PMRA Registration No. 31982      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution for Dogs 4.5 kg and Under

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

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 September 26, 2016 the owner applied the product onto all 5 dogs to treat for fleas.

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

Chihuahua

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 )

4.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

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

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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

Between September 28, 2016 and September 29, 2016 the dog developed symptoms. Between September 29, 2016 and September 30, 2016 the inappetence ended. Between October 7, 2016 and October 8, 2016 the diarrhea ended. On October 26, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated diarrhea a few days after the exposure is not expected. The APSS assistant recommended monitoring the dog at home.

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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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. Signs expected to be mild and self limiting.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

4.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

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

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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

Between September 28, 2016 and September 29, 2016 the dog developed symptoms. Between September 29, 2016 and September 30, 2016 the inappetence ended. Between October 7, 2016 and October 8, 2016 the diarrhea ended. On October 26, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated diarrhea a few days after the exposure is not expected. The APSS assistant recommended monitoring the dog at home.

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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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. Signs expected to be mild and self limiting.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

3.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Bloody diarrhea
  • Symptom - Diarrhea

12. How long did the symptoms last?

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

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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

Between September 28, 2016 and September 29, 2016 the dog developed bloody diarrhea. On September 29, 2016 the owner took the dog to the veterinarian, where fluid therapy was given, radiographs performed, a referral to emergency clinic, pain control and an antibiotic was given. Between September 30, 2016 and October 1, 2016 the bloody diarrhea ended and the dog developed diarrhea. Between October 2, 2016 and October 3, 2016 the dog was discharged from the hospital. Between October 7, 2016 and October 8, 2016 the dog's diarrhea ended. On October 26, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated diarrhea a few days after the exposure is not expected. The APSS assistant recommended 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

Moderate

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

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

2.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

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

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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

Between September 28, 2016 and September 29, 2016 the dog developed symptoms. Between September 29, 2016 and September 30, 2016 the inappetence ended. Between October 7, 2016 and October 8, 2016 the diarrhea ended. On October 26, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated diarrhea a few days after the exposure is not expected. The APSS assistant recommended monitoring the dog at home.

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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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. Signs expected to be mild and self limiting.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Pekingese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

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

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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

Between September 28, 2016 and September 29, 2016 the dog developed symptoms. Between September 29, 2016 and September 30, 2016 the inappetence ended. Between October 7, 2016 and October 8, 2016 the diarrhea ended. On October 26, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated diarrhea a few days after the exposure is not expected. The APSS assistant recommended monitoring the dog at home.

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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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. Signs expected to be mild and self limiting.