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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0213

2. Registrant Information.

Registrant Reference Number: 100113254

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.

29-AUG-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

28-AUG-10

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

  • 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 August 28, 2010 applied the product onto both of the dogs and used the wrong dose on one 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

Lhasa Apso Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.3

7. Weight (provide a range if necessary )

21

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Shaking
  • Skin
    • Symptom - Erythema
  • Gastrointestinal System
    • Symptom - Loss of appetite

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

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 August 28, 2010 the dog became symptomatic. On August 29, 2010 the owner then contacted the Animal Product Safety Service (APSS). The APSS stated that this sounds like a paresthesia type reaction that the dog is experiencing. The APSS veterinarian recommended bathing the dog with liquid dish washing detergent, applying vitamin E to the application after the bathe, and calling back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On August 29, 2010 the owner called the APSS back to update the case. The APSS veterinarian discussed diphenhydramine and Vitamin E use and discussed that no treatment is without risk and take the dog to the veterinarian. Later that evening, the owner contacted the APSS back to further discuss the case. The owner stated the dog now has erythema down his back and out to his ears. The APSS veterinarian discussed whether or not the dog was scratching, he was not. The APSS veterinarian discussed the hyperesthesia response and recommended a cool compress and giving the dog a dose of diphenhydramine, but she would not expect these signs to be life threatening.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Lhasa Apso Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

31

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Shaking
  • Skin
    • Symptom - Erythema
  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

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 August 28, 2010 the dog became symptomatic. On August 29, 2010 the owner then contacted the Animal Product Safety Service (APSS). The APSS stated that this sounds like a paresthesia type reaction that the dog is experiencing. The APSS veterinarian recommended bathing the dog with liquid dish washing detergent, applying vitamin E to the application after the bathe, and calling back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On August 29, 2010 the owner called the APSS back to update the case. The APSS veterinarian discussed diphenhydramine and Vitamin E use and discussed that no treatment is without risk and take the dog to the veterinarian. Later that evening, the owner contacted the APSS back to further discuss the case. The owner stated the dog now has erythema down his back and out to his ears. The APSS veterinarian discussed whether or not the dog was scratching, he was not. The APSS veterinarian discussed the hyperesthesia response and recommended a cool compress and giving the dog a dose of diphenhydramine, but she would not expect these signs to be life threatening.