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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6903

2. Registrant Information.

Registrant Reference Number: 170194445

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-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

03-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)

PMRA Registration No. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg (30 lbs)

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 November 3, 2017 the owner applied the product to the dogs to treat a condition.

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

Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.08

7. Weight (provide a range if necessary )

9.0

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 - Weight loss
    • Symptom - Vomiting
    • Symptom - Bloody diarrhea
    • Symptom - Difficulty swallowing
    • Specify - Dysphagia
    • Symptom - Other
    • Specify - throat burn
  • General
    • Symptom - Swelling

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

Soon after the product was applied on November 3, 2017 the dog developed weight loss (the dog weighed 13 pounds (lbs) before the product was applied and now weighs 9 lbs), vomiting, bloody diarrhea, and dysphagia (owner reports the dog's throat is burned and swollen). At an unknown date and time, the owner took the dog to the regular veterinarian but could not afford treatment. On November 6, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS assistant recommended the owner take the dog to a veterinarian and have the veterinarian call for information.


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

Domestic Unspecified

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 )

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

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Weight loss
    • Symptom - Vomiting
    • Symptom - Bloody diarrhea
    • Symptom - Difficulty swallowing
    • Specify - Dysphagia
  • General
    • Symptom - Swelling
  • Gastrointestinal System
    • Symptom - Other
    • Specify - throat burn

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

Soon after the product was applied on November 3, 2017 the dog developed weight loss (the dog weighed 10 pounds (lbs) before the product was applied and now weighs 6 lbs), vomiting, bloody diarrhea, and dysphagia (owner reports the dog's throat is burned and swollen). At an unknown date and time, the owner took the dog to the regular veterinarian but could not afford treatment. On November 6, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS assistant recommended the owner take the dog to a veterinarian and have the veterinarian call for information.


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.