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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6939

2. Registrant Information.

Registrant Reference Number: 180165524

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.

02-OCT-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-SEP-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)

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

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 September 26, 2018, the owner applied the product to the dog.

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

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

10.9

kg

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
  • Skin
    • Symptom - Edema
    • Symptom - Lesion
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Specify - Inappetence
  • Skin
    • Symptom - Hives

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 September 27, 2018, the dog developed lethargy, edema of the face, and application site lesion (application site appeared as a burn that scabbed over and was oozing with discharge). The owner wiped the application site with a Q-tip to try to remove as much of the product as possible. On October 1, 2018, the dog developed inappetence. Later in the evening, the owner took the dog to the regular veterinarian who gave antibiotics and shaved his fur. Once the dog was shaved, the regular veterinarian noted that the dog had developed hives (urticaria). The regular veterinarian stated that the dog was in septic shock. On October 2, 2018, the owner contacted the Animal Product Safety Service (APSS). The owner stated that the dog still has symptoms but that he is slowly getting his appetite back. The APSS veterinarian stated that the risk is for dermal sensitivity and paresthesia and that oral paresthesia and gastrointestinal (GI) upset can be seen if ingested. The APSS veterinarian stated that it sounds like the dog experienced an allergic reaction to the product and that some dogs are more sensitive to the ingredients in the product. The APSS assistant recommended the owner discontinue product use, continue giving antibiotics, monitor for dermatological signs (keep application site clean and dry until vet visit the following day), have the veterinarian call for information, and to call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here