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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6047

2. Registrant Information.

Registrant Reference Number: 190063314

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.

14-APR-19

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

13-APR-19

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control For Dogs Over 14 kg

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

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-829-89459

Product Name: Adams Pentagon Flea And Tick Spot On For Extra Large Dogs 61-150 Lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE 39.31%
    • ETOFENPROX 50%
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE .91%
    • PIPERONYL BUTOXIDE 9.1%
    • PYRIPROXYFEN 0.45%

7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

26.7

kg

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Respiratory System
    • Symptom - Coughing
  • Gastrointestinal System
    • Symptom - Abnormal feces colour

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 April 13, 2019, the owner gave 0.247 fluid ounces (fl oz) orally, of the Adams Pentagon product to the dog. Later that day, the dog developed symptoms. On April 14, 2019, the owner took the dog to the emergency veterinarian, who did radiographs and placed an IV catheter. Soon after, the emergency veterinary technician contacted the Animal Product Safety Service. The APSS veterinarian stated that the risk is for gastrointestinal (GI) upset. The APSS veterinarian recommended the emergency veterinarian give sucralfate, give a bland diet (for 48 hours), monitor at home, monitor for coughing, give doxycycline (if cough worsens), and to resume therapy (reapply the product in 72 hours (h) dermally).


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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

25.7

kg

8. Route(s) of exposure

Oral

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 - Salivating excessively

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 April 13, 2019, the owner gave 2.0 milliliters (mL) orally of the Zodiac product to the dog. Later that day, the dog developed symptoms. On April 14, 2019, the owner took the dog to the emergency veterinarian, who placed an IV catheter. Soon after, the emergency veterinary technician contacted the Animal Product Safety Service. The APSS veterinarian stated that the risk is for gastrointestinal (GI) upset. The APSS veterinarian recommended the emergency veterinarian rinse the dog's mouth (with water), give a taste treat, and to resume therapy (reapply the product in 72 hours (h) dermally).


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.