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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0147

2. Registrant Information.

Registrant Reference Number: 160145562

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.

29-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

28-SEP-16

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. 31982      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution for Dogs 4.5 kg and Under

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 September 26, 2016 the owner applied the product for the first time onto the dog to treat condition (seeing a flea on the dog).

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

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

6.00

lbs

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

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
    • Specify - Soft Feces
    • Symptom - Abnormal feces colour
    • Specify - Dark Feces
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia

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 September 28, 2016 the dog started vomiting, had soft and dark feces, and developed anorexia. That evening, the owner gave the dog a bland diet (lean ground beef and rice), but the dog was not interested. On September 29, 2016 the dog developed adipsia, so the owner bathed the dog (dog shampoo). Later that morning, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the signs are not consistent with a sensitivity reaction. The APSS assistant recommended taking the dog to the veterinarian (as signs are not likely related to product usage), having the veterinarian call for information, and bathing the dog (with liquid dish washing detergent (LDWD) if the owner wanted to fully remove the product).


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.