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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6056

2. Registrant Information.

Registrant Reference Number: 2013-US-05537

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.


5. Location of incident.


Prov / State: OHIO

6. Date incident was first observed.


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.


PMRA Registration No.       PMRA Submission No.       EPA Registration No. 773-94


  • Active Ingredient(s)
      • Guarantee/concentration 42.5 %

7. b) Type of formulation.


Application Information

8. Product was applied?


9. Application Rate.


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?


Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms


  • Nervous and Muscular Systems
    • Symptom - Paralysis
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Abdominal distension
  • Blood
    • Symptom - Leukocytosis
    • Symptom - Thrombocytopenia
  • General
    • Symptom - Hemorrhage
    • Symptom - Neoplasia
    • Specify - neoplasm

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

13. Was medical treatment provided? Provide details in question 17.


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident


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 05 Jul 2013 a veterinarian called to report that a dog received Activyl TickPlus for Dogs and Puppies (over 44 lb and up to 88 lb), applied to one location on the neck (Extra Label Use) on 21 Jun 2013. Historically, the dog experienced neurologic deficits beginning in early May of 2013, and had surgery for laryngeal hemiplasia 08 Jun 2013 the dog had a history of coughing and dyspnea which progressed over one month, and radiographs on 07 Jun 2013 showed aspiration pneumonia. A specialist performed the surgery on 08 Jun 2013. Both laryngeal folds were affected due to degeneration of the nerve. The dog received Tramadol beginning 08 Jun 2013, a fentanyl patch from 07 Jun 2013 until 10 Jun 2013, cephalexin on 08 Jun 2013 but this was stopped due to adverse effects (GI) and replaced with Clavamox for 7 days. The dog also received acepromazine for sedation if needed (25 mg q 12 hours) but the veterinarian is unaware if this was used. The dog presented on 19 Jun 2013 for a surgical recheck, but the incision had a seroma and the staples were left in an extra week. Activyl Tick Plus was dispensed and applied two days later, on 21 Jun 2013. On 29 Jun 2013 the dog presented to have surgical staples removed (from the surgery that was performed on 08 Jun 2013). The relief veterinarian noted that the dog experienced a distended abdomen and tetraparesis. Blood work performed on 29 Jun 2013 showed elevated WBC and low platelet count. Radiographs showed a mass effect in the abdomen, with displacement of the intestines. An ultrasound was scheduled for 05 Jul 2013. Theophyline was prescribed on 29 Jun 2013 due to the laryngeal hemiplasia. On 01 Jul 2013 the dog received prednisone for the tetraparesis. The differential diagnosis was CNS or spinal cord deficit. The Activyl Tick Plus was not washed off of the dog and they were not suspicious of a correlation. The dog died at home on 04 Jul 2013. A necropsy is planned. Further information is expected. A second dog of similar breed and age (Doc) from the same household received Activyl Tick Plus and is showing similar signs with tetra paresis and spinal pain. This dog is being treated with steroids and antibiotics. This case is reported as 2013 US 05549. A third dog from another household showed similar signs but did not receive Activyl Tick Plus. That dog was treated with antibiotics and recovered. Follow up information received 15 Jul 2013 The veterinarian reported that the necropsy showed a frontal lobe hemorrhage, and a surgical glove in the stomach was thought to be an incidental finding (the dog had surgery the month before). No further information is expected. Follow up information received 08 Aug 2013 The final necropsy report showed two undifferentiated malignancies in the parietal cerebral cortex and hippocampus as well as a well demarcated metastasis to the cervial spinal cord at the level of C4. No further information is expected.

To be determined by Registrant

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


19. Provide supplemental information here