Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-1602
2. Registrant Information.
Registrant Reference Number: 35691
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.
14-APR-21
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
04-APR-21
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: k9 advantix II large dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
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).
On 4-Apr-2021, a 5 year old, 12.04 kg, male neutered Pug in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 2.5 ML LGE 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?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Pug
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
12.04
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Respiratory System
- Symptom - Rapid breathing
- Nervous and Muscular Systems
- Symptom - Muscle spasm
- Symptom - Trembling
- Symptom - Head shaking
- Skin
- Symptom - Lesion
- Symptom - Dermatitis
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
On 4-Apr-2021, an unknown time after application, the dog developed rapid breathing, and muscle spasms on his face. On 4-Apr-2021, an unknown time after application, the pet owner bathed the dog with water. After the bath the dog began trembling, shaking his head, and had soft stools. On 6-Apr-2021 the dog was seen by a veterinarian who found a lesion at one of the application sites at the base of the neck. On 7-Apr-2021 the dog was prescribed Gabapentin. On 14-Apr-2021 the pet owner reported that the lesion at the base of the neck was infected and looked necrotic. The outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here