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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7294

2. Registrant Information.

Registrant Reference Number: 130142851

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.

12-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-OCT-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. 25695      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Premise 2000 Flea Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

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.

Unknown

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 28, 2013 the owner used the spray product to treat the environment for fleas, and the dog may have been exposed via an unknown route. It is unknown if the use of the spray product was per label. That same day the owner applied a spot on product to the dog to treat for fleas; the owner applied the product to the dog again on October 5, 2013. The second exposure to the spot on product was an off-label use.

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

West Highland White Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

15.5

lbs

8. Route(s) of exposure

Skin

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Biting
  • Skin
    • Symptom - Hives
    • Symptom - Lesion
    • Specify - Scab

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?

Other / Autre

specify Contact with treated area and Treatment

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On October 8, 2013 the owner noticed that the dog had pruritus and was biting at her skin. On October 11, 2013 the owner bathed the dog with a flea and tick shampoo. On October 12, 2013 the owner examined the dog's skin a little more closely and noticed that the dog had urticaria and a scab on her left hind leg. That day the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the spray product and the spot on product could cause a dermal hypersensitivity reaction that includes pruritus, dermal hypersensitivity, and pain; however, because the product was applied about 2 weeks ago and the pet had been bathed with the flea and tick shampoo, it was unlikely that the dog's signs were due to the use of the products; rather, if fleas persisted, it would be likely that the pet has an allergy to fleas or other environmental antigens. Regarding the use of the flea and tick shampoo product, the APSS veterinarian stated that the product is not generally consistent with causing the signs the owner described. The APSS assistant recommended that the owner take the dog to the veterinarian and have the veterinarian call for information; she also referred the owner to the products' manufacturer regarding efficacy issues.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Extra Label Use: Owner inappropriately applied treatment twice within 30 days.