Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5614

2. Registrant Information.

Registrant Reference Number: 140118314

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.

17-SEP-14

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

17-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-829-89459

Product Name: Adams Pentagon Flea and Tick Spot On for Extra Large Dogs 61-150 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .23 %
  • ETOFENPROX
    • Guarantee/concentration 50 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .91 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .45 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.247

Units: oz (fl) / oz (liquide)

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 17, 2014 the owner applied the product onto the dog before leaving for work.

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 )

.83

7. Weight (provide a range if necessary )

70.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 September 17, 2014 the owner returned home to find the dog deceased in the yard. The owner contacted the Animal Product Safety Service (APSS). The owner stated the dog appeared to have been dead for several hours as the bees are already around him and there was no evidence of vomiting or diarrhea. The APSS veterinarian stated due to prior history of using agent without problems, would not have expected any this time. The APSS veterinarian recommended taking the dog the veterinarian for a necropsy, having the veterinarian call for information and calling back with questions.

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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 the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 18, 2014 the owner called the APSS to see if the attending veterinarian had contacted the APSS yet to discuss necropsy. On September 24, 2014 the APSS received necropsy interim results. The histopathology report revealed myocardium, renal parenchyma, stomach, hepatic parenchyma, and splenic parenchyma were severely autolyzed and infested by myriad bacilli and pulmonary parenchyma was severely autolyzed (appears to be congested/edematous) and also infected by myriad bacilli. The microscopic diagnosis is severe postmortem autolysis with pulmonary congestion/edema and postmortem overgrowth of bacteria. The microbiology examination is pending. On September 30, 2014 the APSS veterinarian called the owner to discuss necropsy results. The APSS veterinarian stated there was minimal conclusive findings due to the decomposed state of the tissues. On October 14, 2014 the final necropsy results were received. The GCMS showed that none of the toxic organic compounds that can be identified by GCMS screen were present in the liver sample and no etofenprox or metabolic breakdown products were observed.