Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0180

2. Registrant Information.

Registrant Reference Number: 160098211

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.

06-JUL-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-JUL-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. 31367      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot With Smart Shield F&T Control for Dogs Under 14kg

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

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PMRA Registration No. 31366      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot With Smart Shield F&T Control for Dogs Over 14kg

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: count

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 July 1, 2016 the owner applied the products onto the dogs for prevention.

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

Maltese Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.17

7. Weight (provide a range if necessary )

8.0

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 / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Pruritus

12. How long did the symptoms last?

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

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

On July 1, 2016 the dog developed symptoms. On July 2, 2016 the owner bathed the dog (baby shampoo). A short time later the symptoms had resolved. On July 6, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS technician stated some animals can be more sensitive to the ingredients and can experience a dermal reaction. 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

Minor

19. Provide supplemental information here

The APSS technician stated that the substance was considered to have a high likelihood of causing the clinical situation. Signs were 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

Border Collie

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.5

7. Weight (provide a range if necessary )

45.0

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 / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Pruritus

12. How long did the symptoms last?

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

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

On July 1, 2016 the dog developed symptoms. On July 2, 2016 the owner bathed the dog (baby shampoo). A short time later the symptoms had resolved. On July 6, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS technician stated some animals can be more sensitive to the ingredients and can experience a dermal reaction. 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

Minor

19. Provide supplemental information here

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