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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1247

2. Registrant Information.

Registrant Reference Number: 2016-CA-00031

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.

12-JAN-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

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

Product Name: Saber Pour-On

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN

7. b) Type of formulation.

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).

Suspected Lack of Expected Efficacy reported by clinic on 12 Jan 2016. A producer treated approximately 900 head of feeder cattle with Saber Pour-On insecticide in the fall of 2015 (sometime in Nov 2015). Producer reported that now some of the cattle are scratching, with hair loss, indicating a possible lice infestation. Producer concerned that product is not working for control of lice. The producer is going to re-treat cattle on 14 and 15 Jan 2016. The vet will visit farm and exam cattle to confirm diagnosis. He will send photos of affected cattle and confirm numbers affected and dates of initial treatment. Follow-up pending.Follow-up, 14 Jan 2016: On 14 Jan 2016, the vet visited the farm and examined the animals that had been previously treated with Saber Pour-On insecticide. He confirmed that ~10% of the cattle had hair loss in areas typically associated with lice infestation. He also examined a few animals closely, and in areas of hair loss found both nits and live adult lice. The vet confirmed that the cattle entered the feedlot between the 1st week of November and the second week of Dec, 2015. At that time the cattle weighed ~ 600 700 lbs and were treated on arrival with 15 mL of Saber Pour-On insecticide as part of their processing protocol. No more information is expected.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Beef cattle

4. Number of animals affected

90

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

600

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

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
    • Symptom - Hair loss
    • Symptom - Other
    • Specify - lack of efficacy; nits and live adult lice found

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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

Minor

19. Provide supplemental information here