Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0063

2. Registrant Information.

Registrant Reference Number: 120079511

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.

13-JUN-12

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

13-MAY-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. 26493      PMRA Submission No.       EPA Registration No.

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

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

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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.

Unknown

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 May 12, 2012 and again on June 12, 2012 the owner applied 2.0 milliliters (mL) of the product for dogs over 14 kilograms (kg) to each of her two larger dogs and 1.0 mL of the product for dogs under 14 kg to her smaller 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

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

70.0

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

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

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 May 13, 2012, a day after applying the product to the dog, the owner noticed that the dog was symptomatic. On May 17, 2012 the owner noticed that the dog no longer had diarrhea and on May 20, 2012 the dog was no longer lethargic. On June 13, 2012, a day after applying the product to the dog, the owner noticed that the dog had diarrhea. Later that morning, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that some animals can be more sensitive to the ingredients. The APSS technician recommended that the owner bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E to the application site, give a bland diet of boiled rice and kibble, monitor the dog for dermatological signs of redness or itching, call back with questions if any skin irritation was noted, and consult with a veterinarian to discuss other forms of flea and tick prevention.

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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

Later on the morning of June 13, 2012 the owner called the APSS to obtain additional help. The owner stated that she had bathed the dog at the application area only, and the APSS technician advised the owner to re-bathe the dog, washing its whole body.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

55.0

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

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting

• Skin
  • Symptom - Pruritus

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 May 13, 2012, a day after applying the product to the dog, the owner noticed that the dog was symptomatic. On May 17, 2012 the owner noticed that the dog no longer had diarrhea. On June 13, 2012, a day after applying the product to the dog, the owner noticed that the dog had diarrhea and pruritus. Later that morning, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that some animals can be more sensitive to the ingredients. The APSS technician recommended that the owner bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E to the application site, give a bland diet of boiled rice and kibble, monitor the dog for dermatological signs of redness or itching, call back with questions if any skin irritation was noted, and consult with a veterinarian to discuss other forms of flea and tick prevention.

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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

Later on the morning of June 13, 2012 the owner called the APSS to obtain additional help. The owner stated that she had bathed the dog at the application area only, and the APSS technician advised the owner to re-bathe the dog, washing its whole body.

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 )

10.0

7. Weight (provide a range if necessary )

30.0

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

• Gastrointestinal System
  • Symptom - Diarrhea

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 May 13, 2012, a day after applying the product to the dog, the owner noticed that the dog had diarrhea. On May 17, 2012 the owner noticed that the dog no longer had diarrhea. On June 13, 2012, a day after applying the product to the dog, the owner noticed that the dog had diarrhea. Later that morning, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that some animals can be more sensitive to the ingredients. The APSS technician recommended that the owner bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E to the application site, give a bland diet of boiled rice and kibble, monitor the dog for dermatological signs of redness or itching, call back with questions if any skin irritation was noted, and consult with a veterinarian to discuss other forms of flea and tick prevention.

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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

Later on the morning of June 13, 2012 the owner called the APSS to obtain additional help. The owner stated that she had bathed the dog at the application area only, and the APSS technician advised the owner to re-bathe the dog, washing its whole body.