Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5242

2. Registrant Information.

Registrant Reference Number: 2014-US-09404

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.

09-OCT-14

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

09-OCT-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).

Suspect Adverse Reaction: On 09 Oct 2014 an owner reported, to the (name) Poison and Drug Center (RMPDC), that a dog experienced hiccups after application of Activyl Tick Plus for Dogs and Puppies (over 11 lb and up to 22 lb) on 10 Oct 2014. The owner applied the product at 8 am and around 6pm the dog developed hiccups. The dog was bathed. The owner was transferred to owner to the American Society for the Prevention of Cruelty to Animals (ASPCA) for further consult. Follow-up pending ASPCA report.Follow-up 23 Oct 2014, the owner reported the dog was not hiccuping, the dogs body started jerking (coded as muscle spasm NOS) around 3pm on 10 Oct 2014 along with head twitching. The dog had a seizure around 9pm on 10 Oct 2014 and was taken to the emergency clinic for hospitalization. On 11 Oct 2014 the dog was transferred to its regular veterinarian and continued to have seizures, head twitching, and jerking. The owner elected euthanasia on 11 Oct 2014. The owner reports both the attending and emergency veterinarian suspected a brain tumor and do not believe the use of Activyl Tick Plus contributed to the dogs clinical signs. No further information is expected. Company serious upgraded upon follow-up information received. Follow-up 06 Nov 2014: The product application date and start of clinical sign jerking (coded as muscle spasm NOS) is 09 Oct 2014, not 10 Oct 2014. Case correction made. No further 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

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 )

12.0

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

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Muscle twitching
  • Symptom - Muscle spasm
  • Specify - jerking

• Gastrointestinal System
  • Symptom - Other
  • Specify - hiccups

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?

24

Hour(s) / Heure(s)

15. Outcome of the incident

Euthanised / Euthanasie

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

Suspect Adverse Reaction: On 09 Oct 2014 an owner reported, to the (name) Poison and Drug Center (RMPDC), that a dog experienced hiccups after application of Activyl Tick Plus for Dogs and Puppies (over 11 lb and up to 22 lb) on 10 Oct 2014. The owner applied the product at 8 am and around 6pm the dog developed hiccups. The dog was bathed. The owner was transferred to owner to the American Society for the Prevention of Cruelty to Animals (ASPCA) for further consult. Follow-up pending ASPCA report. Follow-up 23 Oct 2014, the owner reported the dog was not hiccuping, the dogs body started jerking (coded as muscle spasm NOS) around 3pm on 10 Oct 2014 along with head twitching. The dog had a seizure around 9pm on 10 Oct 2014 and was taken to the emergency clinic for hospitalization. On 11 Oct 2014 the dog was transferred to its regular veterinarian and continued to have seizures, head twitching, and jerking. The owner elected euthanasia on 11 Oct 2014. The owner reports both the attending and emergency veterinarian suspected a brain tumor and do not believe the use of Activyl Tick Plus contributed to the dogs clinical signs. No further information is expected. Company serious upgraded upon follow-up information received. Follow-up 06 Nov 2014: The product application date and start of clinical sign jerking (coded as muscle spasm NOS) is 09 Oct 2014, not 10 Oct 2014. Case correction made. No further 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

treatment received; Bath, supportive care