Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-4035
2. Registrant Information.
Registrant Reference Number: 2018BS008
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.
12-MAY-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
23-APR-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. 29780
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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).
K9 advantix II Large dog was applied to x an 8 yr old, Male, ShihTzu x Poodle weighing 10.4 kgs on April 23/18 along the dorsal midline.
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
Crossbred (ShihTzu x Poodle)
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
10.4
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Shaking
- Symptom - Irritable
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
Owners noticed 5 hours after application dog became shakey and irritable and would not eat or drink. Owners bathed x twice 2 remove product with unknown shampoo. They did not bring dog into clinic. x had fully recovered by April 25/18.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
B - Possible
Shaking and irritability are not expected after topical product application. Not eating and drinking are unspecific signs. However, reported signs in this case, may be a consequence of the uncomfortable feeling caused by the applied product. Considering short time to onset, a product relation cannot be excluded and is deemed to be possible.