Health Canada
www.hc-sc.gc.ca
Common menu bar links
Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-4544
2. Registrant Information.
Registrant Reference Number: 2022-CA-000150 and 2022-CA-000151
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G 5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
13-MAY-225. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
11-MAY-22Product 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. 31986 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Infestop for Dogs Between 11 and 25kg
- Active Ingredient(s)
- IMIDACLOPRID
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5Units: 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).
Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
American Cocker Spaniel
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
40
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Abdominal distension
- Specify - Gas
- Symptom - Vomiting
- Symptom - Diarrhea
- Symptom - Constipation
- Specify - Straining to defecate
- General
- Symptom - Lethargy
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
On 11May2022 the animal applied the product topically to the dog. Approximately 2-3 hours post application, the dog developed diarrhea, straining to defecate, lethargy, gas, and vomiting. On 12May2022, vomiting resolved. Animal owner contact a veterinarian who recommended withholding food the evening of 13May2022 and starting a bland diet on 14May2022. No further information is expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone Signs were expected to be mild and self-limiting.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
American Cocker Spaniel
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
30
lbs
8. Route(s) of exposure
Skin
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
- Gastrointestinal System
- Symptom - Diarrhea
- Symptom - Constipation
- Specify - Straining to defecate
- General
- Symptom - Lethargy
- Gastrointestinal System
- Symptom - Bloody stool
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
On 11May2022 the animal owner applied the product topically to the dog. The morning of 12May2022, the dog developed diarrhea, straining to defecate, and lethargy. The morning of 13May2022, the dog developed bloody stool. Animal owner contact a veterinarian who recommended withholding food the evening of 13May2022 and starting a bland diet on 14May2022. No further 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
Assessment: This product has a wide margin of safety. If ingested, mild self-limiting GI irritation leading to vomiting and diarrhea may occur. Lethargy may occur due to general malaise from GI upset. Straining to defecate may be reported in dogs with diarrhea. Bloody stool is not expected from this product, though may occur due to individual variation / sensitivity of the dog. Other causes for the dogs symptoms should be considered including dietary indiscretion, other product use, and underlying health conditions. Veterinary examination and diagnostics including may have been able to provide further information about the cause of the clinical signs, but these were not reported. The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.
