Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0069

2. Registrant Information.

Registrant Reference Number: 120059090

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.

07-MAY-12

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

03-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. 19210      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Breakaway Flea and Tick Collar For Cats

• Active Ingredient(s)
  • 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 May 3, 2012 the owner placed a flea and tick collar on each of her three cats to treat for 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Vomiting

• Skin
  • Symptom - Burns (superficial)
  • Symptom - Hair loss

• General
  • Symptom - Lethargy
  • Symptom - Hiding

• Gastrointestinal System
  • Symptom - Loss of appetite
  • Specify - inappetent

• General
  • Symptom - Other
  • Specify - Odor

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?

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 3, 2012, after the owner placed the collar on the cat, she noticed that the cat became pruritic. On May 6, 2012 the owner noticed that the cat was vomiting, had burns on the skin that looked as if they went down to the veins, had alopecia, was lethargic, was hiding, was inappetent, and had an odor of burnt hair. That day, the owner removed the cat's flea and tick collar, prevented further exposure to the product, called her regular veterinarian, and rinsed the cat's coat and skin with water. On May 7, 2012 the owner took the cat to the veterinarian, where the cat was given an antibiotic shot and antibiotic cream, the cat's hair was clipped, and the wound was cleaned. Later that morning, the owner rinsed the cat's coat and skin and confined her in an area away from the other cats in the house. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that some cats will react to collars by scratching, hiding, being lethargic, or walking backwards. The APSS veterinarian also stated that the severity of the cat's signs were unusual, but some cats will react to plastics or to topical agents with dermal lesions. The APSS veterinarian recommended that the owner prevent self-mutilation by putting baby booties on the cat's feet and a child's ear warmer or pet sweater on the cat's neck to prevent trauma from scratching, call back with questions, take the cat to the veterinarian for observation while the owner is at work, and monitor the cat's appetite when offering free-choice and canned food.

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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

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

9.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• 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

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 May 3, 2012, after the owner placed the collar on the cat, she noticed that the cat became symptomatic. On May 4, 2012 the cat had fully recovered. On May 6, 2012 the owner removed the cat's flea and tick collar, prevented further exposure to the product, and called her regular veterinarian. On May 7, 2012 the owner took the cat to the veterinarian; it is unknown if any cares were given. Later that morning, the owner rinsed the cat's coat and skin. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that some cats will react to collars by scratching, hiding, being lethargic, or walking backwards. The APSS veterinarian also stated that these signs usually resolve after removal of the collar and bathing. The APSS veterinarian recommended that the owner 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

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

25.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• 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

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 May 3, 2012, after the owner placed the collar on the cat, she noticed that the cat became symptomatic. On May 4, 2012 the cat had fully recovered. On May 6, 2012 the owner removed the cat's flea and tick collar, prevented further exposure to the product, and called her regular veterinarian. On May 7, 2012 the owner took the cat to the veterinarian; it is unknown if any cares were given. Later that morning, the owner rinsed the cat's coat and skin. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that some cats will react to collars by scratching, hiding, being lethargic, or walking backwards. The APSS veterinarian also stated that these signs usually resolve after removal of the collar and bathing. The APSS veterinarian recommended that the owner 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