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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6036

2. Registrant Information.

Registrant Reference Number: 190016082

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.

28-JAN-19

5. Location of incident.

Country: UNITED STATES

Prov / State: ARIZONA

6. Date incident was first observed.

27-JAN-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. 31983      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution For Dogs Between 4.6 And 11 kg

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %

7. b) Type of formulation.

Liquid

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 January 26, 2019 the owner applied the product to the dog as prevention. It is unknown if the owner consulted a veterinarian before using the product 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

16.0

7. Weight (provide a range if necessary )

7.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle tremors
  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Head tilt
  • Eye
    • Symptom - Nystagmus

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 January 27, 2019, the dog developed ataxia (ataxia of the hind end), tremors, vomiting, and head tilting (left sided). The owner then took the dog to the emergency veterinarian who took radiographs (showed evidence of intervertebral disc disease (IVDD)), did a chemistry profile (3 elevated liver values), provided symptomatic care, gave the dog a bath (with mild soap), provided fluid therapy, and gave maraopitant, protect liver, and gave gabapentin. On January 28, 2019, the dog developed nystagmus and the emergency veterinarian gave the dog meclizine. Later that morning, the emergency veterinarian contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that systemic effects are not expected and that if ingested, mild gastrointestinal (GI) upset is possible. The APSS veterinarian also stated that there is a low risk for topical contact reaction. Finally, the APSS veterinarian stated that they agree that this is more likely vestibular syndrome or another etiology. The APSS veterinarian recommended the emergency veterinarian provide supportive care, provide symptomatic care, do a diagnostic evaluation, and to call back with questions.


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 not related likelihood of causing the clinical situation. It is unknown if a veterinarian was consulted before using the product on the geriatric dog.