Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-5257
2. Registrant Information.
Registrant Reference Number: 2018EB138
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
13-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
12-JUN-18
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. 27581
PMRA Submission No.
EPA Registration No.
Product Name: advantageII small dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4
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).
The patient is a 1 year old, 1.5 kg female spayed Chihuahua. On June 12th, the pet owner applied 1 vial of Advantage II small dog topically on the patient. This is the first time the patient was receiving this product.
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
Dog / Chien
3. Breed
Chihuahua
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
1.5
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
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 - Vomiting
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
Sometime during the next 24 hours the patient vomited and had diarrhea. The patient was not seen by a veterinarian or treated. The outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
B - Possible
Vomiting is an unspecific and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. However, a reaction to accidentally ingested product cannot be excluded in this case. Diarrhea is not expected with appropriate topical product use as inconsistent with the pharmaco-toxicological product profile. But, sign indicating product uptake such as vomiting is seen, as such product relation cannot be excluded entirely. Time to onset is consistent. Overall, a product relation is considered possible.