Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7172

2. Registrant Information.

Registrant Reference Number: 120157592

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.

12-NOV-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-NOV-12

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. 28360      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerband Plus Dual Action Flea And Tick Collar For Dogs

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 November 11, 2012 the owner placed a flea and tick collar on the puppy to treat for fleas. The owner noticed that the puppy licked, chewed on, and accidentally ingested some of the collar. Collar not fitted properly, should not be able to chew.

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 Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

3.0

lbs

8. Route(s) of exposure

Skin

Oral

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 - Shaking
  • Symptom - Ataxia

• General
  • Symptom - Weakness

12. How long did the symptoms last?

>30 min <=2 hrs / >30 min <=2 h

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 November 12, 2012 the owner noticed that the puppy was symptomatic. Later that morning, to puppy's signs had ended. A short time later, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the ingredients in the flea and tick collar have a wide margin of safety in dogs and that significant systemic signs would not be expected. The APSS veterinarian also stated that if the collar were chewed or licked, drooling or gagging and retching could be seen. The APSS assistant recommended that the owner take the puppy to the veterinarian, have the veterinarian call for information, 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

Moderate

19. Provide supplemental information here

A follow up was not performed, because additional information was not expected. Therefore, the outcome of this case is unknown. Extra Label Use, collar not fitted properly.