Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7260

2. Registrant Information.

Registrant Reference Number: 130124144

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.

04-SEP-13

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

30-AUG-13

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)

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

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.66

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 August 30, 2013 the owner inappropriately applied approximately 0.66 milliliters (mL) of the product to the dog to prevent fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

20.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Restlessness

• General
  • Symptom - Vocalizing

• Respiratory System
  • Symptom - Panting

• Gastrointestinal System
  • Symptom - Vomiting

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 August 30, 2013 the owner noticed that the dog was symptomatic. The owner bathed the dog a short time later that evening. About half an hour later, the dog was no longer restless or vocalizing, but the panting continued and worsened early on the morning of August 31, 2013. A short time later on the morning of August 31, 2013 the owner called her regular veterinarian, and per her advice gave the dog 25 milligrams (mg) of Diphenhydramine; the owner gave the Diphenhydramine each evening after that. The dog was no longer panting a short time after the initial dose of Diphenhydramine. On September 4, 2013 the owner noticed that the dog had vomited twice, with only fluid in the vomitus. A short time later that morning the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS assistant recommended that the owner bathe the dog with liquid dish washing detergent (LDWD), repeat the bath once to ensure all of the product had been removed, and call back with questions.

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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 high likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Therefore, the outcome of this case is unknown. Extra Label Use: owner gave wrong dose of product.