Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-3540

2. Registrant Information.

Registrant Reference Number: 2014-US-07624

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.

25-AUG-14

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

22-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. 773-95

Product Name: ACTIVYL TICK PLUS TOY DOG

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

---

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).

Suspected adverse reaction: On 25 Aug 2014 a vet reported that a litter of puppies became ill and one died following administration of Activyl Tick Plus for Dogs and Puppies (over 4 lbs and up to 11 lbs), Nobivac Canine 1-DAPPv, pyrantel pamoate, and a neem shampoo. The owner of the pups left them with his sister while he traveled. While there, the pups became infested with fleas and ticks. The pups were brought in for grooming where they were bathed with an unknown neem shampoo. When dry, Activyl Tick Plus was administered, the pups were vaccinated with Nobivac Canine 1-DAPPV, and they were dosed with pyrantel pamoate for hooks (4+) and rounds (2+). The evening of 22 Aug 2014 the pups seemed sleepy (coded as lethargic). On the morning of 23 Aug 2014 the pups were normal and active. A second dose of pyrantel was administered by the owner the afternoon of 23 Aug 2014. All the pups developed lethargy and one pup developed seizures. The seizuring puppy died on the way to the clinic that evening (23 Aug 2014). The morning of 25 Aug 2014, one pup remained lethargic and the rest were normal. The second pup died on 25 Aug 2014. The remaining pups appeared normal. A necropsy was offered but neither pup was submitted for necropsy. The Activyl was obtained from the groomer. No further information is expected.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Saint-Bernard

4. Number of animals affected

6

5. Sex

Male

Female

6. Age (provide a range if necessary )

0.16

7. Weight (provide a range if necessary )

10.0

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

• General
  • Symptom - Lethargy
  • Symptom - Death

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

Suspected adverse reaction: On 25 Aug 2014 a vet reported that a litter of puppies became ill and one died following administration of Activyl Tick Plus for Dogs and Puppies (over 4 lbs and up to 11 lbs), Nobivac Canine 1-DAPPv, pyrantel pamoate, and a neem shampoo. The owner of the pups left them with his sister while he traveled. While there, the pups became infested with fleas and ticks. The pups were brought in for grooming where they were bathed with an unknown neem shampoo. When dry, Activyl Tick Plus was administered, the pups were vaccinated with Nobivac Canine 1-DAPPV, and they were dosed with pyrantel pamoate for hooks (4+) and rounds (2+). The evening of 22 Aug 2014 the pups seemed sleepy (coded as lethargic). On the morning of 23 Aug 2014 the pups were normal and active. A second dose of pyrantel was administered by the owner the afternoon of 23 Aug 2014. All the pups developed lethargy and one pup developed seizures. The seizuring puppy died on the way to the clinic that evening (23 Aug 2014). The morning of 25 Aug 2014, one pup remained lethargic and the rest were normal. The second pup died on 25 Aug 2014. The remaining pups appeared normal. A necropsy was offered but neither pup was submitted for necropsy. The Activyl was obtained from the groomer. No further information is expected.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Please note a total of 6 puppies were treated and reacted, 4 recovered and 2 died.