Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-2452

2. Registrant Information.

Registrant Reference Number: 2012-US-04467

Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)

Address: 16750 Transcanada Highway

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-JUN-12

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

21-JUN-12

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. 100-1066-773

Product Name: Grenade ER

• Active Ingredient(s)
  • LAMBDA-CYHALOTHRIN
    • Guarantee/concentration 9.7 %

---

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: 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 27 Jun 2012, an owner reported an adverse event with Grenade ER Premise Insecticide in a dog (extra label use). The owner's home was treated with the product by an exterminator on 20 Jun 2012. On 21 Jun 2012, the dog developed vomiting and on 22 Jun 2012, the dog developed lethargy, panting, and a fever and was hospitalized. On 23 Jun 2012, the dog developed enlarged lymph nodes and facial edema and died. The owner noted that the vet was concerned that envenomation from a spider was a possible cause of the signs noted. No more information is expected.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

63.0

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy
  • Symptom - Fever

• Respiratory System
  • Symptom - Panting

• Blood
  • Symptom - Other
  • Specify - enlarged lymph nodes

• General
  • Symptom - Edema
  • Symptom - Death

12. How long did the symptoms last?

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

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

Euthanised / Euthanasie

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

---

To be determined by Registrant

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

Death

19. Provide supplemental information here