Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-5452

2. Registrant Information.

Registrant Reference Number: 2013 US 07992

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.

19-SEP-13

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

Unknown

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. 773 95

Product Name: ACTIVYL TICK PLUS

• Active Ingredient(s)
  • INDOXACARB TECHNICAL
  • PERMETHRIN
    • Guarantee/concentration 42.5 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.5

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 19 Sep 2013, limited information was received regarding potential deaths in puppies after being treated with an unknown size of Activyl Tick Plus. The puppies were treated with Activyl Tick Plus, possibly Activyl Tick Plus for Dogs and Puppies (over 4 lb and up to 11 lb) at an unknown time in August 2013. The treatment was extra label due to the age of the puppies. The puppies died within 7 hours. A necropsy was performed and noted acute necrotizing enterocolitis and pulmonary edema. The puppies had also received two vaccinations that brand names were not confirmed but were a DM (unknown agents) and a CPV. The puppies had also been given a pyrantel dewormer at the same time. The product was purchased by a veterinarian with the shelter s account. The lot code is not known. No more information is expected.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Mixed Breed

4. Number of animals affected

5

5. Sex

Unknown

6. Age (provide a range if necessary )

0.078

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Diarrhea

• Respiratory System
  • Symptom - Pulmonary edema

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Other
  • Specify - acute necrotizing enterocolitis

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 19 Sep 2013, limited information was received regarding potential deaths in puppies after being treated with an unknown size of Activyl Tick Plus. The puppies were treated with Activyl Tick Plus, possibly Activyl Tick Plus for Dogs and Puppies (over 4 lb and up to 11 lb) at an unknown time in August 2013. The treatment was extra label due to the age of the puppies. The puppies died within 7 hours. A necropsy was performed and noted acute necrotizing enterocolitis and pulmonary edema. The puppies had also received two vaccinations that brand names were not confirmed but were a DM (unknown agents) and a CPV. The puppies had also been given a pyrantel dewormer at the same time. The product was purchased by a veterinarian with the shelter's account. The lot code is not known. No more information is expected.

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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