Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5592

2. Registrant Information.

Registrant Reference Number: 140085238

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.

09-JUL-14

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

09-JUL-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. 2724-813-270

Product Name: Adams Flea and Tick Spot On for Cats and Kittens 5 Lbs and Over

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 40 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 July 9, 2014 the owner applied the product to her kitten. The kitten shook his head and the owner thinks he was able to lick some of the product off.

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

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• 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 July 9, 2014 the owner noticed the kitten started hypersalivating, so the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the risk is for mild, self-limiting gastrointestinal (GI) upset. The APSS assistant recommended providing the cat with a taste treat, giving nothing by mouth, monitoring the cat at home, and calling back with questions. On July 10, 2014 the owner bathed the cat with liquid dish washing detergent (LDWD). Later that day, the owner noticed the kitten was lethargic. On July 11, 2014 the owner noticed the cat was anorexic, so the owner then called the APSS back. The APSS veterinarian recommended taking the kitten to the veterinarian and having the veterinarian call for information. On July 12, 2014 the owner called the APSS back to state that the kitten had died that morning. The owner also stated the kitten didn't improve and he was not taken to the veterinary clinic. A necropsy was recommended.

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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 June 18, 2014 the necropsy interim results were received. The report stated the animal has necrotizing enteritis and pneumonia. The report further stated immunohistchemical staining for feline coronavirus and feline panleukopenia virus have been requested. A final report will follow. On July 22, 2014 the final necropsy results were received. The report stated immunohistchemical staining has been performed for feline coronavirus (lung) and feline parvovirus (small intestine) and both were negative. The report further stated based on the case findings this animal has a necrotizing enteritis with secondary septicemia likely of bacterial origin. The report finally stated no further tests are pending.