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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2934

2. Registrant Information.

Registrant Reference Number: 2013-US-04070

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.

21-MAY-13

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

6. Date incident was first observed.

21-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. 773-92

Product Name: Ultra Saber Pour On

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

On 21 May 2013, a veterinarian reported that a producer vaccinated about 51 head of Angus calves weighing around 250 pounds with 20/ 20 Vision 7, poured them with Ultra Saber and put fly tags in their ears. Within minutes of vaccination, one heifer began to show signs of anaphylaxis with blood tinged foam and froth coming out of her nose and mouth. The vet administered epinephrine but the heifer died. She was not necropsied. No further follow up 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

Cow / Vache

3. Breed

Angus Beef

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.2

7. Weight (provide a range if necessary )

250

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Anaphylaxis
  • Respiratory System
    • Symptom - Coughing up blood
  • General
    • Symptom - Death

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

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 21 May 2013, a veterinarian reported that a producer vaccinated about 51 head of Angus calves weighing around 250 pounds with 20/ 20 Vision 7, poured them with Ultra Saber and put fly tags in their ears. Within minutes of vaccination, one heifer began to show signs of anaphylaxis with blood tinged foam and froth coming out of her nose and mouth. The vet administered epinephrine but the heifer died. She was not necropsied. No further follow up expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here