Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6218

2. Registrant Information.

Registrant Reference Number: 140064011

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.

26-MAY-14

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

24-MAY-14

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 Fleatrol Power Spot Flea and Tick Control for Dogs Under 14 kg

• 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 May 24, 2014 the groomer inappropriately applied the product on the dog in 3 locations down the back instead of only at neck area.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Bichon Frise

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

26.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Trembling

• General
  • Symptom - Polydipsia

• Nervous and Muscular Systems
  • Symptom - Restlessness

• Skin
  • Symptom - Erythema

• General
  • Symptom - Vocalizing

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 May 24, 2014 the dog developed trembling, polydipsia, restlessness, and erythema. On May 26, 2014 the dog began vocalizing, so the owner bathed the dog with oatmeal shampoo. A short time later, a distribution company representative contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated permethrin can cause a tingling sensation to the skin and sensitive dogs can develop pruritus, agitation, changes in gait, lethargy, panting, or hiding. The APSS veterinarian also stated some dogs will develop alopecia and secondary dermal lesions from scratching the affected area. The APSS veterinarian further stated systemic central nervous signs (CNS) signs are not expected in dogs. The APSS veterinarian finally stated since this was only supposed to be placed on one area of the skin, he is most likely having a lot of paraesthesia since it's on multiple areas. The APSS assistant recommended applying Vitamin E, rinsing the coat and skin in luke warm water, and calling back with questions. The distribution company representative called the APSS back to provide further details. She stated the owner did give a second water bath on May 26, 2014. The APSS veterinarian recommended taking the dog to the veterinarian if the dog isn't back to normal by the next day, have the veterinarian call for information, and apply a cold compress at application sites.

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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