Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0249

2. Registrant Information.

Registrant Reference Number: 120141417

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.

09-OCT-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control For Cats And Kittens

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

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7. b) Type of formulation.

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).

Sometime around the middle of September, the owner applied the product to a 20 month old cat to prevent fleas. A day after applying the product to the 20 month old cat, the owner applied the product to a 5 year old cat to prevent fleas.

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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

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 )

15.0

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

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Dermatitis

• General
  • Symptom - Licking
  • Symptom - Vocalizing

• Skin
  • Symptom - Pruritus
  • Symptom - Hair loss

• General
  • Symptom - Hiding

• Skin
  • Symptom - Dermatitis
  • Specify - Flea Allergy Dermatitis

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

Between September 9 and September 29, 2012 the owner noticed that the cat was symptomatic. Between October 6 and October 7, 2012 the owner bathed the cat with warm water only. On October 9, 2012 the owner took the cat to the veterinarian, where the cat was diagnosed with flea allergy dermatitis and given a flea treatment (that was not applied yet). Later that morning, the owner's friend contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal irritation and/or contact hyperesthesia could occur, as with any topical exposure.

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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

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.67

7. Weight (provide a range if necessary )

8.0

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Licking

• Skin
  • Symptom - Pruritus
  • Symptom - Hair loss
  • Symptom - Lesion
  • Specify - Abscess

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?

No

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

Between September 6 and September 26, 2012 the owner noticed that the cat was symptomatic. Between September 7 and September 27, 2012 the owner noticed that the cat has an abscess. Between September 8 and September 28, 2012 the owner took the cat to the veterinarian, where a penicillin injection was given to the cat and an Elizabethan collar was placed on the cat. Between September 15 and October 5, 2012, the cat's licking had ended and she no longer had pruritus or an abscess; however, the cat still had alopecia. On October 9, 2012 the owner's friend contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal irritation and/or contact hyperesthesia could occur, as with any topical exposure.

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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