Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0181

2. Registrant Information.

Registrant Reference Number: 160100699

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.

10-JUL-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

10-JUL-16

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea and Tick Control for Dogs Over 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.

2

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 July 10, 2016 the owner applied the wrong dose of the product for treatment.

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

Toy Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin
  • Specify - Rubbing Application Site

• General
  • Symptom - Vocalizing
  • Symptom - Hiding

• Nervous and Muscular Systems
  • Symptom - Abnormal gait

• Skin
  • Symptom - Erythema

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 July 10, 2016 the dog developed symptoms. The owner then bathed the dog (3 times with Dawn). Shortly after the owner took the dog to the veterinarian. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated permethrins and pyrethroids can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus. The APSS veterinarian also stated occasionally animals will develop sores or scabs, and alopecia secondary to scratching or biting the application site. The APSS veterinarian further stated 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 additionally stated 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 assistant recommended having the attending veterinarian call for information and calling 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

This was off label use pf the product. The wrong dose of the product was used on the dog. A short time later the attending veterinarian called the APSS with an update to discuss the case. The APSS veterinarian discussed the case with attending veterinarian and recommended bathing the dog (oatmeal or skin soothing shampoo), vitamin E, cold compress, symptomatic and supportive care, and calling back with questions.