Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6455

2. Registrant Information.

Registrant Reference Number: 130101556

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.

23-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

09-JUL-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.       PMRA Submission No.       EPA Registration No. 2724-814

Product Name: Kirkland Signature Flea And Tick Control For Cats 5lbs and over

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

---

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 8, 2013 the owner applied the product to 2 of her cats to treat for fleas. Unknown if owner contacted veterinarian before use on geriatric cats.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Persian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hiding

• Nervous and Muscular Systems
  • Symptom - Ataxia

• 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

Between the evening of July 8, 2013 and the evening of July 9, 2013 the owner noticed that the cat was hiding. Between the evening of July 10, 2013 and the evening of July 11, 2013 the owner noticed that the cat was ataxic. On July 13, 2013 the owner observed that the cat had died. On July 23, 2013 the owner contacted the company to obtain help. The company's veterinarian stated that topical use of synthetic pyrethroid-like flea preparations as per label directions is not expected to cause significant clinical signs. The company's call center staff advised the owner to contact the Animal Product Safety Service (APSS) to report the incident.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

The company's veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A necropsy was not available. Unknown if owner contacted veterinarian before use on geriatric and debilitated cat. Flea anemia suspected to be positive.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Persian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hiding
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Vocalizing
  • Symptom - Dehydration

• Blood
  • Symptom - Anemia

• Nervous and Muscular Systems
  • Symptom - Seizure

• Respiratory System
  • Symptom - Laboured breathing
  • Specify - Agonal Breathing

• General
  • Symptom - Death

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

Between the evening of July 8, 2013 and the evening of July 9, 2013 the owner noticed that the cat was hiding. On July 13, 2013 the owner noticed that the cat was lethargic and was hiding more than before. The company's veterinarian stated that topical use of synthetic pyrethroid-like flea preparations as per label directions is not expected to cause significant clinical signs. The company's call center staff advised the owner to contact the Animal Product Safety Service (APSS) to discuss the case.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

On July 26, 2013 the owner stated that on July 23, 2013 the cat was anorexic and adipsic. The owner stated that she had been providing nutritional support via syringe feeding; she did not provide dates/times. The owner stated that on July 24, 2013 she took the cat to the veterinarian; that day the cat was vocalizing when being picked up, dehydrated, and anemic. At the veterinary clinic the cat received a diagnostic evaluation and a blood transfusion was planned. On the morning of July 25, 2013 the cat had a seizure prior to the blood transfusion; during the blood transfusion the cat had a seizure, experienced agonal breathing, and died. A necropsy was not available. Unknown if owner contacted veterinarian before use on geriatric and debilitated cat. Flea anemia suspected to be positive.