Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6874
2. Registrant Information.
Registrant Reference Number: 2018EB246
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.
25-OCT-18
5. Location of incident.
Country: CANADA
Prov / State: NEW BRUNSWICK
6. Date incident was first observed.
23-OCT-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. 27583
PMRA Submission No.
EPA Registration No.
Product Name: advantageII medium dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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 October 23rd, the pet owner applied 1 vial of Advantage II medium dog on a 3 year old male neutered 4.54kg Chihuahua in generally good health.
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
Chihuahua
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
4.54
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
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
Approximately 12 hours after the application, the patient's face began to swell up and hives appeared all over his body. The pet owner treated with Benadryl at home.
The patient was evaluated by a veterinarian on October 24th, the facial swelling had gone down but the hives were still present. The patient was treated with prednisone. The outcome is unknown.
No more information is expected, Case closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
B - Possible
In individual cases hypersensitivity reactions to the product are possible in animals that are particular sensitive. Short time to onset suggests a product connection is possible.