Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6906

2. Registrant Information.

Registrant Reference Number: 170203187

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.

20-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-NOV-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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Flea and Tick Spray For Dogs and Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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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 October 30, 2017 and November 13, 2017 the owner applied the product to the three dogs 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

Dog / Chien

3. Breed

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10.5

7. Weight (provide a range if necessary )

65.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Dermatitis
  • Symptom - Pruritus

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 November 18, 2017 the dog developed symptoms. On November 20, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS assistant stated that dermal irritation or contact hypersensitivity may occur as with any topical exposure and in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS assistant recommended the owner provide flea treatment (discuss with veterinarian (DVM)), take the dog to a veterinarian (for a physical examination (PE)), and to 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

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

Golden Retriever

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 )

60.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Dermatitis
  • Symptom - Pruritus

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 November 18, 2017 the dog developed symptoms. On November 20, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS assistant stated that dermal irritation or contact hypersensitivity may occur as with any topical exposure and in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS assistant recommended the owner provide flea treatment (discuss with veterinarian (DVM)), take the dog to a veterinarian (for a physical examination (PE)), and to 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

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

Miniature Dachshund

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

15.0

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

• Skin
  • Symptom - Pruritus
  • Symptom - Dermatitis
  • Symptom - Hair loss
  • Symptom - Lesion
  • Specify - Scabs

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 November 2, 2017 the dog developed pruritus and dermatitis. On November 3, 2017 the owner put an Elizabethan collar on the dog. On November 13, 2017 the dog developed alopecia (hair loss), scabs, and the pruritus and dermatitis both became moderate. On November 20, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS assistant stated that dermal irritation or contact hypersensitivity may occur as with any topical exposure and in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS assistant recommended the owner provide flea treatment (discuss with veterinarian (DVM)), take the dog to a veterinarian (for a physical examination (PE)), and to 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

Signs were expected to be mild and self-limiting.