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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-5885

2. Registrant Information.

Registrant Reference Number: 2017-CA-01517

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.

14-JUN-17

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

12-JUN-17

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?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

0.40

7. Weight (provide a range if necessary )

19

kg

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea

12. How long did the symptoms last?

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

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

Unknown/Inconnu

16. How was the animal exposed?

Other / Autre

specify perhaps the dog has licked the product or may have layed on the spilled product.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

Suspected Adverse Reaction reported by attending veterinarian on 14 Jun 2017. The producer administered Saber Pour On to his cattle, on 13 Jun 2017, and accidently dropped the jug on the floor. That night, one of his dog was acting strange (unknown which dog). Both his dogs were ataxic on the next day. No tremors were observed. The producer thinks that perhaps the dogs have licked the product or may have layed on the spilled product. The dogs were brought for a vet exam that day. Other than ataxia, the exam was normal. Heart rate and body temperature were normal. The dog reported in this case (21 week old Border collie) had loose stool and vomiting. Blood panel was normal on both dogs. Vet doesn't think these dogs could have been exposed to something else but performed an Ethylene Glycol test to rule out this possibility- results are pending. At time of reporting, the dogs had not been treated yet. The other dog is reported in case 2017-CA-01516. Follow-up, 16 Jun 2017: The company sales representative spoke with the attending vet. He said that the dog has recovered. He did mention that a third dog from this ranch came in on 15 Jun 2017 and it was treated and doing better now. More information is expected. Follow-up, 21 Jun 2017: Multiple unsuccessful attempts were made to collect additional information on this third dog since clinical signs and dog's specifics are unknown. Also, details on diagnostic results / treatments could not be obtained. No more information is expected. The vet mentioned that another dog from this ranch came in on 15 Jun 2017 and it was treated and doing better now


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

18.8

kg

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
  • Nervous and Muscular Systems
    • Symptom - Ataxia

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify perhaps the dog has licked the product or may have layed on the spilled product.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

Suspected Adverse Reaction reported by attending veterinarian on 14 Jun 2017. The producer administered Saber Pour On to his cattle, on 13 Jun 2017, and accidently dropped the jug on the floor. That night, one of his dog was acting strange (unknown which dog). Both his dogs were ataxic on the next day. No tremors were observed. The producer thinks that perhaps the dogs have licked the product or may have layed on the spilled product. The dogs were brought for a vet exam that day. Other than ataxia, the exam was normal. Heart rate and body temperature were normal. Blood panel was normal on both dogs. Vet doesn't think these dogs could have been exposed to something else but performed an Ethylene Glycol test to rule out this possibility- results are pending. At time of reporting, the dogs had not been treated yet. The other dog is reported in case 2017-CA-01517. Follow-up, 16 Jun 2017: The company sales representative spoke with the attending vet. He said that the dog has recovered. Follow-up, 21 Jun 2017: Multiple attempts were made to collect information on diagnostic results and treatments without success. No more information is expected.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here