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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6143

2. Registrant Information.

Registrant Reference Number: 140123096

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.

28-SEP-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-SEP-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)

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

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 September 23, 2014 the owner applied the product onto the dog after finding what he thought was evidence of fleas.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

60.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Subdued
  • Skin
    • Symptom - Hair loss
    • Symptom - Dermatitis

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 September 23, 2014 the dog became subdued right after the product was applied. On September 28, 2014 the owner noticed symptoms at the site of application. The APSS veterinarian stated the ingredients in this agent have a wide margin of safety in dogs. The APSS veterinarian also stated dermal reactions in sensitive individuals can be seen and significant systemic effects are not expected. The APSS assistant recommended monitoring the dog at home, applying a warm compress (gently clean the area with warm, wet cloth), monitoring for dermatological signs (worsening dermatitis), calling back with questions, taking the dog to the veterinarian (if signs are worsening), and having the veterinarian call for information.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On September 30, 2014 the owner called the APSS back to update the case. The owner stated he took the dog to the veterinarian; where they clipped hair (at the site of application), provided wound management (wound was cleansed and treated with an ointment and the owner was sent home with soap and ointment to keep the area clean) , and an antibiotic (cephalexin) was given. The APSS veterinarian stated it is possible to see mild local dermal irritation, redness, itching, and alopecia in some sensitive dogs. The APSS assistant recommended continuing treatment (as directed by the vet) as that is appropriate care, and calling back with questions. Signs were expected to be mild and self-limiting.