Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6033

2. Registrant Information.

Registrant Reference Number: 2014-US-11350

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.

04-DEC-14

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

21-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)

PMRA Registration No. 27829      PMRA Submission No.       EPA Registration No. 773-74

Product Name: Saber Pour On

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN
      • Guarantee/concentration 1 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

15

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).

Lack of Efficacy. On 4 December 2014 a producer reported that he purchased a 104 head of steers on 20 October 2014. These are local calves. Calves were vaccinated with Once PMH IN, Inforce3, Virashild6, SafeGuard, Saber Pour On and Compudose Implant. The next day 1 calf was quite lame in the right rear foot and did not respond to treatment. About 10 days after initial vaccination the calves were revaccinated with Express 5 and Excede. Shortly after revaccination 2 more calves came up lame in the right rear foot. These two responded to treatment but the 1st calf had to be euthanized. In the last couple of weeks a couple more calves have shown up lame in the right rear foot. On 15 November 2014 the producer purchased another 80 head of steer and after vaccinating them the same as the first group he had 5 calves within a few days show up lame in the right rear foot. None have improved with treatment. Owner suspects Mycoplasma or Histophilus. Lab work is pending.

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

Cow / Vache

3. Breed

MIxed bovine

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.6

7. Weight (provide a range if necessary )

500.0

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Lameness

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?

No

14. b) How long was the animal hospitalized?

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

Lack of Efficacy. On 4 December 2014 a producer reported that he purchased a 104 head of steers on 20 October 2014. These are local calves. Calves were vaccinated with Once PMH IN, Inforce3, Virashild6, SafeGuard, Saber Pour On and Compudose Implant. The next day 1 calf was quite lame in the right rear foot and did not respond to treatment. About 10 days after initial vaccination the calves were revaccinated with Express 5 and Excede. Shortly after revaccination 2 more calves came up lame in the right rear foot. These two responded to treatment but the 1st calf had to be euthanized. In the last couple of weeks a couple more calves have shown up lame in the right rear foot. On 15 November 2014 the producer purchased another 80 head of steer and after vaccinating them the same as the first group he had 5 calves within a few days show up lame in the right rear foot. None have improved with treatment. Owner suspects Mycoplasma or Histophilus. Lab work is pending.


To be determined by Registrant

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

Death

19. Provide supplemental information here