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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-3872
2. Registrant Information.
Registrant Reference Number: 2021-CA-01919
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.
05-JUL-215. Location of incident.
Country: CANADA
Prov / State: MANITOBA
6. Date incident was first observed.
04-JUL-21Product 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
- Guarantee/concentration 1 %
- 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
Cat / Chat
3. Breed
unknown
4. Number of animals affected
2
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Unknown
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Staggering
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Fully Recovered / Complètement rétabli
16. How was the animal exposed?
Other / Autre
specify Product was spilled on a deck and pet accidentally came into contact with it.
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Suspected Adverse reaction and Extra Label Use (Species) reported by a clinic on 05 Jul 2021. On 04 Jul 2021, a bottle of Saber Pour On spilled on the porch of a pet owners house and 2 dogs and multiple cats were possibly exposed to the product. This case is for the multiple cats. The pet owner noticed that some cats were seen stumbling but was unable to catch them to have them examined by a veterinarian. No further information was available for the multiple cats. The other cases were reported in 2021-CA-01920, 2021-CA-01921. Follow-up is expected. Further information was provided on 06 Jul 2021. There was 2 cats affected and they are reported to be back to normal. 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
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Lancashire Heeler dog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
23
kg
8. Route(s) of exposure
Unknown
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Anorexia
- General
- Symptom - Adipsia
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Fully Recovered / Complètement rétabli
16. How was the animal exposed?
Other / Autre
specify Product was spilled on a deck and pet accidentally came into contact with it.
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Suspected Adverse reaction and Extra Label Use (Species) reported by a clinic on 05 Jul 2021. On 04 Jul 2021, a bottle of Saber Pour On spilled on the porch of a pet owners house and 2 dogs and multiple cats were possibly exposed to the product. This case is for the 5 year old Lancashire Heeler dog of 23.0kg. This dog did not want to eat or drink and he was taken to the clinic for examination. No treatment had been dispensed at the time of the report. The other cases were reported in 2021-CA-01919, 2021-CA-01921. Follow-up is expected. Further information was provided on 6 Jul 2021: Once examined at the clinic the dog was back to normal and sent home. No more information is expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Not Applicable
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
Lancashire Heeler dog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
21
kg
8. Route(s) of exposure
Unknown
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Blood
- Symptom - Hyperglycemia
- Symptom - Hypokalemia
- Symptom - Leukocytosis
- Gastrointestinal System
- Symptom - Anorexia
- Symptom - Vomiting
- General
- Symptom - Adipsia
- Symptom - Dehydration
- Symptom - Malaise
- Nervous and Muscular Systems
- Symptom - Ataxia
- General
- Symptom - Subdued
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
24
Hour(s) / Heure(s)
15. Outcome of the incident
Fully Recovered / Complètement rétabli
16. How was the animal exposed?
Other / Autre
specify Product was spilled on a deck and pet accidentally came into contact with it.
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Suspected Adverse reaction and Extra Label Use (Species) reported by a clinic on 05 Jul 2021. On 04 Jul 2021, a bottle of Saber Pour On spilled on the porch of a pet owners house and 2 dogs and multiple cats were possibly exposed to the product. This case is for the 3 year old Lancashire Heeler dog of 21.0kg. This dog vomited and did not want to eat or drink and he was taken to the clinic for examination. No treatment had been dispensed at the time of the report. The other cases were reported in 2021-CA-01919, 2021-CA-01920. Follow-up is expected. Further information was provided on 06 Jul 2021. The case was upgraded to local serious with this new information. The dog was kept for observation overnight as he was not feeling well (subdued: verbatim). Blood work showed elevated white blood cells, low Potassium, elevated glucose and signs of dehydration. The dog was put on intravenous fluids with K+. some vomiting was observed. Neurological exam was normal on 05 July 2021 but some sign were noticed on 6 July (ataxia). The pet owner explained to the clinic that the only way the dog could have gotten into contact with the product would be that the cats walked in the product and walked in the water bowl thereafter which seems highly unlikely according to the veterinarian (oral exposure). The vomiting as since stopped with Cerenia treatment and the dog did eat in clinic. The dog was sent home with FortiFlora, Cerenia and subcutaneous fluids to administer if needed, for observation for financial reasons. Follow-up is expected. Follow-up 21 Jul 2021. The clinic reports that the dog had recovered by the end of the day on 06 Jul 2021, all clinical signs had resolved, and was released from the clinic. No follow up blood test was performed. No more information is expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Not Applicable
19. Provide supplemental information here
clinically well but bloodwork not repeated
