Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5601

2. Registrant Information.

Registrant Reference Number: 140101411

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.

12-AUG-14

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

11-AUG-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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-797-89459

Product Name: Bio Spot Active Care Flea and Tick Spray for Dogs and Puppies

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .27 %
  • ETOFENPROX
    • Guarantee/concentration .5 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 1.75 %

---

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 August 9, 2014 the owner bathed the under labelled aged puppy with dish soap and then applied the a few light sprays of the product from a distance. The owner then sold the puppy to a pet store.

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.17

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Eye
  • Symptom - Other
  • Specify - Absent Blink Reflex

• Nervous and Muscular Systems
  • Symptom - Semi comatose

• 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

On August 11, 2014 the pet store noticed the puppy was symptomatic, so the puppy was taken to the veterinary clinic, where they provided thermoregulation. On August 12, 2014 the owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated although the product was used off label a light mist is not expected to be a serious concern. The APSS veterinarian also stated overuse of the product may cause alcohol intoxication.

---

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 18, 2014 an APSS assistant called the owner to follow up on the puppy. On August 12, 2014 the puppy was semi comatose and died a few hours later. The owner stated the attending veterinarian believes the puppy had a congenital defect. A necropsy was not available. Extra Label Use: Puppy was under labelled age.