Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5160

2. Registrant Information.

Registrant Reference Number: 2013-US-03329

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.

03-MAY-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

03-MAY-13

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

• 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.

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).

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.5

7. Weight (provide a range if necessary )

30.0

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

• Gastrointestinal System
  • Symptom - Diarrhea

• Nervous and Muscular Systems
  • Symptom - Muscle weakness
  • Symptom - Stiffness

• Blood
  • Symptom - Leukocytosis
  • Specify - neutrophilia

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Difficulty getting up
  • Specify - dogs back legs kept collapsing

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?

Unknown

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 03 May 2013, a pet owner reported, to the RMPDC, that a dog had an adverse experience after the application of Activyl Spot On for Dogs and Puppies (over 11 lb and up to 22 lb). The product was applied on 02 May 2013. Twelve hours later, on 03 May 2013, the owner noted the dog developed diarrhea and the dog's back legs kept collapsing. RMPDC recommended to seek veterinary attention. It is unknown where the Activyl Tick Plus was purchased. Follow-up pending. Follow-up 10 May 2013, the pet owner reported the diarrhea was an isolated incident that resolved on 03 May 2013. A veterinarian was contacted on 03 May and recommended to bathe the dog in Dawn dish washing soap. The owner bathed the dog on 03 May. The pet owner stated on 03 May the dog experienced hind end limb stiffness that is ongoing and is still experiencing collapse of the hind end. Veterinary intervention was recommended if the problems persists. Follow up pending. Follow up 13 May 2013: The dog presented to the clinic today and the vet stated that she feels the dogs knees were irritated from being down so long. She is going to do radiographs and bloodwork. The product was purchased from the vet clinic. Follow up pending.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Blood work results: elevated white blood cell count. Waiting for information on radiograph results and update on dog. Follow up pending. Follow-up on 31 May 2013, the veterinarian reported the radiograph results revealed hip dysplasia and luxating patellas. The veterinarian suspects the diarrhea may have weakened the dog, which then wasn't supported by already existing bad joints. The dog is responding well to Rimadyl. The veterinarian stated further follow-up is not needed. No further information is expected. Follow up on 15 May 2014; Activyl Tick Plus for Dogs and Puppies (over 11 lb and up to 22 lb) was applied on 30 lb dog (low dose-extra label use) not Activyl Spot On for Dogs and Puppies (over 11 lb and up to 22 lb) as previously reported. The owner reported that the muscle weakness continued since May 2013; On 03 Feb 2014, the dog developed daily seizured that continued until the dog died on 20 Feb 2014. Bloodwork did not reveal a cause and the dog passed away prior to a neurology appointment. No more information is expected.