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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2283

2. Registrant Information.

Registrant Reference Number: 2015-US-04345

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.

25-APR-15

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

23-MAR-15

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: UltraBoss

  • 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.

1.5

Other Units: ml per 50 lbs

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).

Adverse Reaction. On 25 April 2015 a producer reported that she applied Ultra Boss to her 9 does and 5 bucks on 21 April 2015 according to label directions. She noticed when she went to milk 2 does a couple days later on 23 April that the does teats seemed sensitive and the next morning they were warm and leathery. The does hair was also starting to fall out and their skin was flaking. The producer washed the goats with soap and water. The goats seems to be in pain and is trembling and has stopped eating. Multiple layers of skin have come off the worst is on her back and now down her sides and hips. On 29 April 2015 the producer reported that the goats had developed diarrhea. On 30 April 2015 1 goat died. Goat is being collected for necropsy and diagnostic. Follow up pending.Follow up 6 May 2015: The goat was unable to be necropsied and without proper necropsy we will not be able to determine cause of death. The producer does not think that the teat issues is a result of mastitis as she sends milk samples in every week. The skin lesions of the other goats are resolving and no samples will be taken. No more information 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

Other / Autre

specify Goat

3. Breed

Nubian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

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

  • General
    • Symptom - Death
  • Skin
    • Symptom - Hair loss
    • Symptom - Dry skin
    • Specify - Flaking
  • General
    • Symptom - Other
    • Specify - Teats are sensitive,warm and leathery
    • Symptom - Pain
  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Specify - systemic shaking
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Diarrhea

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

treatment provided;washed with soap and water. Vitamin B, Dexamethasone, fluid therapy, silver sufadiazine


To be determined by Registrant

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

Death

19. Provide supplemental information here

Nothing to add.