Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7226

2. Registrant Information.

Registrant Reference Number: 130095103

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.

11-JUL-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-JUN-13

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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PMRA Registration No. 28382      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Dual Action Flea And Tick Spray For Cats And Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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PMRA Registration No. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray For Dogs and Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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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.

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 June 27, 2013 the owner applied 1.0 milliliters (mL) of the spot on product to one of her cats to treat for fleas; the owner inappropriately repeated the use of the product on July 4, 2013. The owner also inappropriately sprayed the same cat with 2 different flea and tick sprays weekly during the same time frame. On June 27, 2013 the owner also applied the same two flea and tick sprays to 2 other cats and applied a flea and tick collar to both of them to treat for fleas; the owner treated the cats with the 2 spray products again on July 4, 2013.

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

Medical Professional

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 )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite

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 June 27, 2013 the owner noticed that the cat was symptomatic; despite the cat's signs, the owner reapplied the 3 flea and tick products to the cat again on July 4, 2013. On July 11, 2013 the owner took the cat to the veterinarian, and the owner's regular veterinarian contacted the Animal Product Safety Service to obtain help a short time later. The APSS veterinarian stated that with the spot on product and the 2 spray products there was a risk for dermal hypersensitivity reactions and other behavior changes, possibly to carriers. Regarding the 2 spray products, the APSS veterinarian stated that the products contained a low percentage of pyrethroids that could cause some degree of paresthesia; although the product labels stated that the products could be used weekly, the use of multiple products simultaneously likely had a cumulative effect and would not be advised. The APSS veterinarian recommended that the owner's regular veterinarian bathe the cat with a liquid dish washing detergent (LDWD) or with Oxydex shampoo, perform a diagnostic evaluation, provide symptomatic and supportive care, call back with questions, and obtain additional information about products used for environmental control; the APSS veterinarian also consulted with the regular veterinarian about alternative flea control.

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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

Extra label use, owner inappropriately applied products, this was used in combination with other flea products and likely had cumulative dose.

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite

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 June 27, 2013 the owner noticed that the cat was symptomatic; despite the cat's signs, the owner reapplied the 3 flea and tick products to the cat again on July 4, 2013. On July 11, 2013 the owner took the cat to the veterinarian, and the owner's regular veterinarian contacted the Animal Product Safety Service to obtain help a short time later. The APSS veterinarian stated that with the spot on product and the 2 spray products there was a risk for dermal hypersensitivity reactions and other behavior changes, possibly to carriers. Regarding the 2 spray products, the APSS veterinarian stated that the products contained a low percentage of pyrethroids that could cause some degree of paresthesia; although the product labels stated that the products could be used weekly, the use of multiple products simultaneously likely had a cumulative effect and would not be advised. The APSS veterinarian recommended that the owner's regular veterinarian bathe the cat with a liquid dish washing detergent (LDWD) or with Oxydex shampoo, perform a diagnostic evaluation, provide symptomatic and supportive care, call back with questions, and obtain additional information about products used for environmental control; the APSS veterinarian also consulted with the regular veterinarian about alternative flea control.

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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

Extra label use, owner inappropriately applied products, this was used in combination with other flea products and likely had cumulative dose.