Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6952

2. Registrant Information.

Registrant Reference Number: 180006406

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-JAN-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

10-JAN-18

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. 26494      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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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 January 9, 2018 the owner applied the product to the four dogs to treat a condition.

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

Dog / Chien

3. Breed

Pug

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 )

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Hyperactivity
  • Symptom - Rubbing face

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Polydipsia

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 January 10, 2018 the dog developed symptoms. On January 11, 2018 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrins and pyrethroids can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus and that occasionally animals will develop sores or scabs, and alopecia secondary to scratching or biting the application site. The APSS veterinarian also stated that some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (ex. take a few steps, stop, sit down and turn quickly toward their tail). The APSS veterinarian further stated that signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours and that oral exposures can lead to hypersalivation, vomiting, and diarrhea. The APSS veterinarian continued by stating that s-methoprene is an insect growth regulator (IGR) and that the primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. Finally, the APSS veterinarian stated that the signs these dogs are having are not totally consistent. The APSS assistant recommended the owner bathe the dog and 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

Signs were expected to be mild and self-limiting.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9.0

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Polydipsia

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 January 10, 2018 the dog developed symptoms. On January 11, 2018 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrins and pyrethroids can cause a tingling sensation to the skin. The APSS veterinarian also stated that some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (ex. take a few steps, stop, sit down and turn quickly toward their tail). The APSS veterinarian further stated that signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. The APSS veterinarian continued by stating that s-methoprene is an insect growth regulator (IGR) and that the primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. Finally, the APSS veterinarian stated that the signs these dogs are having are not totally consistent. The APSS assistant recommended the owner bathe the dog, take the dog to a veterinarian (if ataxia continues), and to call 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 not related likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Respiratory System
  • Symptom - Wheezing
  • Symptom - Coughing

• General
  • Symptom - Polydipsia

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 January 10, 2018 the dog developed symptoms. On January 11, 2018 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrins and pyrethroids can cause a tingling sensation to the skin. The APSS veterinarian also stated that some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (ex. take a few steps, stop, sit down and turn quickly toward their tail). The APSS veterinarian further stated that signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. The APSS veterinarian continued by stating that s-methoprene is an insect growth regulator (IGR) and that the primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. Finally, the APSS veterinarian stated that the signs these dogs are having are not totally consistent. The APSS assistant recommended the owner take the dog to a veterinarian (if signs continue) and have the veterinarian call for information.

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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 not related likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Head shaking

• General
  • Symptom - Polydipsia

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 January 10, 2018 the dog developed symptoms. On January 11, 2018 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrins and pyrethroids can cause a tingling sensation to the skin. The APSS veterinarian also stated that some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (ex. take a few steps, stop, sit down and turn quickly toward their tail). The APSS veterinarian further stated that signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. The APSS veterinarian continued by stating that s-methoprene is an insect growth regulator (IGR) and that the primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. Finally, the APSS veterinarian stated that the signs these dogs are having are not totally consistent. The APSS assistant recommended the owner clean the dog's ears (with liquid dish washing soap (LDWS)).

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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 veterinarian stated that the substance was considered to have a not related likelihood of causing the clinical situation.