Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6557
2. Registrant Information.
Registrant Reference Number: 2018BS038
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.
28-AUG-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
03-JUL-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).
1 dose of K9 advantix II large was applied to the dorsal midline to a 5 year old, 10.5 kg, F/S Miniature Schnauzer.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Miniature Schnauzer.
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
10.5
kg
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
- Respiratory System
- Symptom - Other
- Specify - noisy breathing
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?
Unknown
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
Was lethargic 6 hours after application for approx. 5 days later, inappetent and had noisy breathing. Dog was bathed and given Benadryl by the pet owner. Dog s skin twitchy. Outcome unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
O - Unclassifiable/unassessable Lethargy and later reported inappetence are unspecific signs and may have multiple potential other causes in a dog. Even though Permethrin has the potential to cause slight neurological disorder in particular susceptible animal, twitching is not expected after long time. Noisy breathing is not expected either. Other causes should be considered. Though time to onset is consistent for lethargy, it is long for later reported signs. Considering overall aspects, a product connection is unassessable.