Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7026

2. Registrant Information.

Registrant Reference Number: 170119801

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.

14-JUL-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

29-JUN-17

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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Powerspot With Smartshield Flea & TIck For Dogs

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

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PMRA Registration No. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Double Action Flea And Tick Shampoo For Dogs And Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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PMRA Registration No. 31367      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg (30 lbs)

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

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PMRA Registration No. 31368      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II With Smart Shield 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.

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 April 25, 2017 the owner applied the spray to the two dogs and two cats to treat a flea infestation. On June, 29, 2017 the owner applied the cat spot on product to the cats. The owner has been bathing all four animals with the shampoo since purchasing on June 29, 2017. On June 30, 2017 the owner applied the dog spot on product to the dogs.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Parson Russell Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

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

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

Shortly after the dog was bathed on June 29, 2017 the dog developed pruritus. On July 14, 2017 the owner contacted the Animal Product Safety Service (APSS) for information on how to control the flea infestation and to obtain help with the pruritus. The APSS veterinarian stated that the risk for all products is for a dermal hypersensitivity reaction and taste reaction. The APSS assistant recommended the owner call a veterinarian (to consult about more effective products), bathe the dog (oatmeal bath to soothe skin), environmental decontamination (vacuum to help remove fleas/eggs, properly dispose of result), and provide flea treatment (could try an oral medication).

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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

The APSS assistant stated that the substances were not considered to be related to causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Parson Russell Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

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

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

Shortly after the dog was bathed on June 29, 2017 the dog developed pruritus. On July 14, 2017 the owner contacted the Animal Product Safety Service (APSS) for information on how to control the flea infestation and to obtain help with the pruritus. The APSS veterinarian stated that the risk for all products is for a dermal hypersensitivity reaction and taste reaction. The APSS assistant recommended the owner call a veterinarian (to consult about more effective products), bathe the dog (oatmeal bath to soothe skin), environmental decontamination (vacuum to help remove fleas/eggs, properly dispose of result), and provide flea treatment (could try an oral medication).

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

The APSS assistant stated that the substances were not considered to be related to causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.

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 )

6.0

7. Weight (provide a range if necessary )

28.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

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

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

Shortly after the cat was bathed and the spot on product was applied on June 29, 2017 the cat developed pruritus. On July 14, 2017 the owner contacted the Animal Product Safety Service (APSS) for information on how to control the flea infestation and to obtain help with the pruritus. The APSS veterinarian stated that the risk for all products is for a dermal hypersensitivity reaction and taste reaction. The APSS assistant recommended the owner call a veterinarian (to consult about more effective products), bathe the cat (oatmeal bath to soothe skin), environmental decontamination (vacuum to help remove fleas/eggs, properly dispose of result), and provide flea treatment (could try an oral medication).

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

The APSS assistant stated that the substances were not considered to be related to causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.

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 )

5.0

7. Weight (provide a range if necessary )

20.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

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

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

Shortly after the cat was bathed and the spot on product was applied on June 29, 2017 the cat developed pruritus. On July 14, 2017 the owner contacted the Animal Product Safety Service (APSS) for information on how to control the flea infestation and to obtain help with the pruritus. The APSS veterinarian stated that the risk for all products is for a dermal hypersensitivity reaction and taste reaction. The APSS assistant recommended the owner call a veterinarian (to consult about more effective products), bathe the cat (oatmeal bath to soothe skin), environmental decontamination (vacuum to help remove fleas/eggs, properly dispose of result), and provide flea treatment (could try an oral medication).

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

The APSS assistant stated that the substances were not considered to be related to causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.