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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7192

2. Registrant Information.

Registrant Reference Number: 130057747

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.

04-MAY-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-MAY-13

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg

  • 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 May 3, 2013 the owner applied the product to the dog to prevent 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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Hesitancy to move
    • Symptom - Hiding
  • Respiratory System
    • Symptom - Panting
  • General
    • Symptom - Vocalizing
  • Skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Nervous and Muscular Systems
    • Symptom - Recumbent

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 3, 2013 through the 4th, the owner noticed that the dog was symptomatic. A short time later, the owner bathed the dog with an oatmeal shampoo for dogs. A short time after bathing the dog, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product's ingredients have a wide margin of safety in dogs and that dermal and dermal paresthesia reactions could be seen, although significant systemic effects would not be expected. The APSS assistant recommended that the owner bathe the dog with a mild liquid dish washing detergent (LDWD), monitor the dog at home for dermatological signs, apply vitamin E topically once a day as needed, apply a cold compress, give food, call back with questions, and consult with a veterinarian.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Later on the morning of May 4, 2013 a different owner contacted the APSS to update the case. The owner stated that she had applied vitamin E oil, but the dog remained symptomatic. The owner also stated that, in addition to the other signs, the dog was also recumbent on the morning of May 4, 2013. On May 5, 2013 the owner's emergency veterinarian contacted the APSS to update the case. The emergency veterinarian stated that the dog remained symptomatic and showing signs of paresthesia. The APSS veterinarian recommended that the emergency veterinarian give the dog 25 to 50 milligrams per kilogram (mg/kg) of Methocarbamol by mouth, give the dog Diazepam, and give the dog 2 mg/kg of Diphenhydramine by mouth every 8 to 12 hours.