Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6487

2. Registrant Information.

Registrant Reference Number: 130121428

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-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

29-AUG-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-490

Product Name: Vet Kem Siphotrol Plus II Premise Spray

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .085 %
  • D-PHENOTHRIN
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration 2 %
  • PERMETHRIN
    • Guarantee/concentration .35 %

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7. b) Type of formulation.

Liquid

Other (specify)

aerosol

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On August 29, 2013 the owner sprayed the product in a room in her home; the room was unventilated. That day, the cat was accidentally exposed to the product when he entered the room. That day another company's spot on product was also applied to the cat to prevent fleas.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Unknown

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 - Lethargy

• Eye
  • Symptom - Pupil dilation

• Blood
  • Symptom - Anemia

• General
  • Symptom - Hyperthermia

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death
  • Symptom - Parasitism
  • Specify - Hemobartonella felis

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On August 29, 2013 the owner noticed that the cat was lethargic and mydriatic. The owner immediately rinsed the cat with water and contacted the Animal Product Safety Service (APSS) a short time later to obtain help. The APSS assistant recommended that the owner take the cat to the veterinarian and have the veterinarian call for information.

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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 August 30, 2013 the owner called the APSS to update the case. The owner stated that on the evening of August 29, 2013 she took the cat to the veterinarian, where laboratory tests revealed that the cat was anemic, hyperthermic, and had a parasite of the blood. The owner declined the emergency veterinarian's recommendations to perform a blood transfusion and euthanize the cat. The emergency veterinarian gave the cat Prednisone and an antibiotic and was later discharged from the clinic. The owner said that the cat had a seizure and died on the evening of August 30, 2013. The APSS veterinarian stated that Hemobartonella felis (also known as Mycoplasma haemofelis) was considered to have a high likelihood of causing the clinical situation. A necropsy was not available.