Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2019-5468
2. Registrant Information.
Registrant Reference Number: 30617
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-AUG-19
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
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.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: k9 advantix II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 an unknown date in Apr 2019, a 8 year old, of unknown weight, neutered, male, Pug canine, in unknown condition, with concomitant medical conditions of seizures, was administered 1 tube of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) topically by the owner. The product size was in kilograms.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
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 )
8
7. Weight (provide a range if necessary )
Unknown
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Skin
- Symptom - Other
- Specify - Warm to the touch
- General
- Symptom - Abnormal behaviour
- Gastrointestinal System
- Symptom - Abdominal distension
- Specify - Flatulence
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
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
An unspecified time post administration, the canine felt warm to the touch on his ears, exhibited hypersalivation, changed behavior and flatulence. He was not examined or treated by a veterinarian. On an unknown date in approximately Apr2019, the clinical signs resolved. On approximately 10Aug2019, the canine exhibited pruritus. No further information is expected. Case is closed.Please note I tried to reach Dr. (name) for more information but I was unable to reach her
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here