Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-5303
2. Registrant Information.
Registrant Reference Number: 2018CK066
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.
18-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
13-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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII extra large 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).
8yr fs golden doodle 55lbs treated with k9 advantix II XL on june 13th.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
golden doodle
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
34.4
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
- Nervous and Muscular Systems
- Symptom - Loss of coordination
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.
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?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
the dog was vaccinated on june 12th. on the evening of june 13th, the dog was acting lethargic and appeared uncoordinated - (acting strangely). recovered on june 15th. no treatment required. The attending veterinarian was unsure whether the signs were related to a vaccine reaction or the K9 advantix II XL
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
B - Possible
Lethargy is an unspecific sign. However, it may represent a behavioural response to the product sensation. Even though more expected after oral uptake, permethrin has the potential to cause slight neurological disorders e.g. incoordination in particular susceptible animals. Considering consistent time to onset, a product connection is deemed to be possible.