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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6115

2. Registrant Information.

Registrant Reference Number: 190137699

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.

05-AUG-19

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

30-JUL-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.       PMRA Submission No.       EPA Registration No. 2724-497

Product Name: Zodiac Spot On Flea And Tick Control For Puppies Dogs 7-15 Lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.65

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 July 30, 2019, the owner applied the product to the dog to treat a condition. It is unknown if the owner consulted with a veterinarian before use on the geriatric dog.

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

Papillon

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.0

7. Weight (provide a range if necessary )

11.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Respiratory System
    • Symptom - Dyspnea
    • Symptom - Other
    • Specify - Deep Breathing
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Renal System
    • Symptom - Other
    • Specify - Not Urinating
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Absent Bowl Movements
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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

Within 30 minutes of the product being applied on July 30, 2019, the dog developed symptoms. On July 31, 2019, the owner took the dog to the regular veterinarian who gave an antihistamine and antibiotics. Later that night on July 31, 2019, the dog passed away. On August 5, 2019, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that some animals are more sensitive to the ingredients than others, and that oral exposures can lead to hypersalivation, vomiting, and diarrhea. Finally, the APSS veterinarian stated that systemic effects, breathing difficulties or renal/liver issues are not expected. The APSS veterinarian recommended the owner call back with questions.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A necropsy was unavailable, as the dog had already been buried. It is unknown if a veterinarian was consulted before use on the geriatric dog.