Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0136

2. Registrant Information.

Registrant Reference Number: 100092310

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.

16-JUL-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

16-JUL-10

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. 26496      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On 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).

On July 15, 2010 the owner inappropriately applied the product onto the nursing cat.

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

Cat / Chat

3. Breed

Domestic Shorthair mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

9

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Fasciculations

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Seizure

• Renal System
  • Symptom - Inappropriate urination

• Gastrointestinal System
  • Symptom - Inappropriate defecation

• Nervous and Muscular Systems
  • Symptom - Recumbent
  • Symptom - Trembling

• Gastrointestinal System
  • Symptom - Anorexia

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Hypersensitivity

• General
  • Symptom - Lethargy

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 July 16, 2010 the cat began hypersalivating, vomiting, and having fasciculations. Later that night the owner called the Animal Product Safety Service (APSS). The APSS veterinarian stated a taste reaction may be seen from the odor or taste of the product. The APSS veterinarian also stated dermal hypersensitivity can occur in some cats and dermal lesions may raise this risk. During the APSS consultation, the cat began to seizure, had an episode of inappropriate urination and defecation, became recumbent, anorexic, hypersensitive, lethargic, and started trembling. The APSS veterinarian recommended bathing the cat with liquid dish washing detergent, monitoring the cat at home, obtain additional information on the agent used, and calling 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

The APSS veterinarian stated that the substance was considered to have a low likelihood of causing the clinical situation. On July 20, 2010 an APSS assistant contacted the owner to follow up the case. The owner stated the cat had fully recovered on July 18, 2010 and no veterinary care was sought. On July 25, 2010 an APSS veterinarian contacted the owner concerning hair testing. The owner stated she would speak with her attending veterinarian regarding the hair testing. The product was not used according to label directions: do not use on nursing animals.