Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-8165
2. Registrant Information.
Registrant Reference Number: 2017CP370
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.
21-NOV-17
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
18-NOV-17
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: Advantage II 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 November 18 2017 , a 6.08 kg, 6 year old female neutered canine cross with no concomitant medical conditions , was applied one tube advantageII medium dog once topically by the owner.
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
Crossbred
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
6.08
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Specify - Rolling
- Symptom - Vocalizing
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
4
Hour(s) / Heure(s)
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
On November 18 2017 , a 6.08 kg, 6 year old female neutered canine cross with no concomitant medical conditions , was applied one tube advantageII medium dog once topically by the owner; a few hours after application, the dog was rolling on her back, was vocalizing and had loose stool ; dog was examined by a veterinarian on November 21 and treated with IV fluids; dog recovered in the afternoon of November 21.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
B - Possible
A behavioural response to the product sensation or to the product smell is possible. Loose stools are not expected with appropriate topical product use. No oral product exposure witnessed and no signs indicating product uptake such as salivation or vomiting seen. Time to onset is short. Considering all aspects, a product connection is possible.