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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2016-2356

2. Registrant Information.

Registrant Reference Number: 2016-US-01537

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.

06-FEB-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

06-FEB-16

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. 773-84

Product Name: Ultra Boss Pour On

  • Active Ingredient(s)
    • PERMETHRIN
      • Guarantee/concentration 5 %
    • 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).

Suspected Adverse Reaction. On 6 Feb 2016, a veterinarian reported that a group of 40 bulls were poured with Ultra Boss and vaccinated with Fusoguard. Later that night, one bull was panting and had a bloody nose. He reported that the owner thought the bulls had been rough housing around. The next morning, the owner found the bull dead. The bull had a bloody/ frothy discharge around his nose and mouth. On 7 Feb 2016, the owner found another bull that had died during the night with no previous clinical signs. On 10 Feb 2016, the veterinarian reported that he necropsied the bulls the morning of 7 Feb 2016 and samples were submitted to the diagnostic lab-follow up 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

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Angus

4. Number of animals affected

2

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

1100

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

  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Panting
    • Symptom - Other
    • Specify - Foam in trachea
  • Gastrointestinal System
    • Symptom - Foaming at mouth
  • Respiratory System
    • Symptom - Epistaxis

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


To be determined by Registrant

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

Death

19. Provide supplemental information here