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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-3487
2. Registrant Information.
Registrant Reference Number: 36515
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.
08-JUL-215. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
Unknown
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
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
- IMIDACLOPRID
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4Units: 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 7-Jul-2021, a 6 year old, 3.41 kg, female neutered Chihuahua in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 0.4 ML SM DOG, (-), by Animal owner. The product was used according to label (Yes). This dog received this product in the past and experienced a adverse reaction (see case 36516), and another patient in the same home experienced similar symptoms (see case 36512 and 36514). On -Mar-2021, a 6 year old, 3.41 kg, female spayed Chihuahua in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 0.4 ML SM DOG, (-), by Animal owner. The product was used according to label (Yes).To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
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 )
6
7. Weight (provide a range if necessary )
3.41
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Irritable
- Symptom - Head shaking
- Skin
- Symptom - Itchy skin
- Nervous and Muscular Systems
- Symptom - Head tilt
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
7-July-2021 application: A few hours after application the dog became irritated, was shaking its head, and was scratching at the application site. The dog also developed a head tilt. The pet owner was advised they could apply vitamin E oil or bathe the dogs with degreasing soap. The outcome is unknown. Mar-2021 application: Within hours the dog became irritated, was shaking its head, and scratching at the application site. The symptoms lasted for 1 week then the dog recovered without treatment. Please see related case 36515 (same patient) and cases 36514 and 36512 (cluster- same home).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
