Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1799

2. Registrant Information.

Registrant Reference Number: 120154941

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.

06-NOV-12

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

05-NOV-12

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.       PMRA Submission No.       EPA Registration No. 2724-811-270

Product Name: Adams Flea And Tick Spot On For Dogs For Use Only On Extra Large Dogs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 30 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 5 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

9

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 November 2, 2012 the owner applied the product to the dog to treat for fleas. At that time, the owner also gave the dog 4.0 fluid ounces (fl oz) of a worming product as a preventative.

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

German Shepherd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.5

7. Weight (provide a range if necessary )

125.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

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

Died

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 November 5, 2012 the owner discovered the dog's dead body. Per the owner, the dog could have died anytime between Friday, November 2, 2012 and Monday, November 5, 2012. On November 6, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that etofenprox in the spot on product is classified as both a pyrethroid-like insecticide and a non-ester pyrethroid and is safe to use on cats and dogs; it's use does not result in tremors or seizure activity that can be seen from other pyrethroids because it is structurally different. A necropsy was not available because the dog had already been buried.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that neither product was considered to be related to causing the clinical situation. The APSS veterinarian stated that gastric dilatation and volvulus was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.