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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0018

2. Registrant Information.

Registrant Reference Number: 150081493

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.

18-JUN-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

16-JUN-15

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)

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

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 June 16, 2015 the owner applied the inappropriate dose of product onto the dogs for prevention.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.667

7. Weight (provide a range if necessary )

50.0

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

  • General
    • Symptom - Abnormal behaviour
    • Specify - rolling
  • Skin
    • Symptom - Blister
    • Symptom - Erythema

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

Not recovered / Non 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 June 16, 2015 the dog was rolling on the ground so the owner bathed the dog in an antifungal dog shampoo. Later that afternoon, the dog developed additional symptoms. On June 18, 2015 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated with this product, we could see dermal signs (erythema, pruritus, paraesthesia). The APSS veterinarian further stated that some animals exhibit abnormal behavior in response to the skin sensation caused by dermal application. The APSS assistant recommended take the dog to the veterinarian, have the veterinarian call for information, and referral to the manufacturer (for complaints/reimbursement questions).


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On June 22, 2015 an APSS technician called the owner to follow up on the case. The owner stated that on June 19, 2015 both dogs were seen at the regular veterinarian and placed on antibiotics. The owner further noted that Zeke's blistered area is drying up. Off label use of wrong size dose used on dog.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.667

7. Weight (provide a range if necessary )

52.5

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

  • General
    • Symptom - Abnormal behaviour
    • Specify - rolling
  • Skin
    • Symptom - Blister
    • Symptom - Erythema

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

Not recovered / Non 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 June 16, 2015 the dog was rolling on the ground so the owner bathed the dog in an antifungal dog shampoo. Later that afternoon, the dog developed additional symptoms. On June 18, 2015 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated with this product, we could see dermal signs (erythema, pruritus, paraesthesia). The APSS veterinarian further stated that some animals exhibit abnormal behavior in response to the skin sensation caused by dermal application. The APSS assistant recommended take the dog to the veterinarian, have the veterinarian call for information, and referral to the manufacturer (for complaints/reimbursement questions).


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On June 22, 2015 an APSS technician called the owner to follow up on the case. The owner stated that on June 19, 2015 both dogs were seen at the regular veterinarian and placed on antibiotics. The owner further noted that Zack's blistered area is still present and much the same. Off label use wrong size dose used on dog.