Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0051

2. Registrant Information.

Registrant Reference Number: 2014-US-11600

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.

15-DEC-14

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

15-DEC-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)

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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.

1

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).

Suspected Adverse Reaction: On 17 Dec 2014 APSS was contacted by RMPDC about a call that was received on either 15 Dec 2014 or 17 Dec 2014. A pet owner applied Activyl Tick Plus for Dogs and Puppies (over 11 lb and up to 22 lb) to her 7 pound cat on 14 Dec 2014 (extra label use - species). The product was obtained from an unidentified source. On 15 Dec 2014 the cat exhibited anorexia, lethargy, abnormal breathing, hypothermia, and on 17 Dec 2014 the cat continued with these signs and head pressing. The cat presented for emergency care on 15 Dec 2014, as well as on 17 Dec 2014. According to the technician on 18 Dec 2014, the cat died at the veterinary hospital on 18 Dec 2014. No further 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

Cat / Chat

3. Breed

Domestic short hair cross breed

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 )

7.0

lbs

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

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

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Respiratory System
  • Symptom - Difficulty Breathing
  • Specify - Abnormal breathing

• General
  • Symptom - Hypothermia
  • Symptom - Abnormal behaviour
  • Specify - Head Pressing

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?

2

Day(s) / Jour(s)

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

Treatment received; Bathed with Dawn Dish Soap, Fluids, force fed, antibiotics, Two injections of steroids

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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