Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0076

2. Registrant Information.

Registrant Reference Number: 150000553

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-JAN-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

01-JAN-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)

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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 December 30, 2014 the owner applied the wrong dose of product onto the dog.

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

Miniature Poodle

4. Number of animals affected

1

5. Sex

Male

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Hair loss
  • Symptom - Lesion
  • 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 January 1, 2015 the dog developed symptoms. The owner then rinsed the dog's coat/skin and applied iodine. On January 2, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated permethrin is a pyrethroid, dogs tolerate pyrethroids well, and no life threatening signs expected. The APSS veterinarian also stated pyrethroids can cause a "pins and needles" sensation or hyperesthesia, resulting in reluctance to move, mild tremors, paw shaking, ear twitching or facial fasciculations. The APSS veterinarian finally stated some dogs will develop erythema and pruritus as well. The APSS assistant recommended bathing the dog (using liquid dish washing detergent (LDWD), monitoring the dog at home, taking the dog to the veterinarian (if signs do not improve), having the 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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a high likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Therefore, the outcome of this case is unknown. Signs were expected to be mild and self-limiting. Off label use-wrong dose of Over 30 lb product used on 10 lb dog.