Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-4736
2. Registrant Information.
Registrant Reference Number: 2018TH045
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.
04-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
18-MAY-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. 29777
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix II Small Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- 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).
On May 18 2018 a pet owner applied 1 tube of K9 advantix II small dog to a 2.9 kg 2 yr old MN yorkie X.
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
Crossbred (Dog)
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
2.9
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
- Skin
- Symptom - Itchy skin
- Symptom - Pruritus
- Specify - Application site self trauma
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
- Symptom - Anorexia
12. How long did the symptoms last?
Unknown / Inconnu
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?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
The dog developed application site itching and scratched the area raw overnight. The dog developed diarrhea, inappetance and vomiting on May 23. The dog was treated for this on May 24 with an unknown medication
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
O - Unclassifiable/unassessable
Whereas skin reaction at application site, e.g. itching may occur in sensitive animals, would not expect application site self trauma directly related to product. However, likely linked to scratching at application site which caused sign by self-trauma. Reported digestive disorders are very unspecific signs and may have potential other causes in an animal. No oral product exposure reported. Inappetence is also very unspecific and is likely a consequence of digestive signs. Even though time to onset is consistent for reported application site disorders, considering long time to onset (5 days) for other reported signs, a product connection is unassessable.