Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-2890
2. Registrant Information.
Registrant Reference Number: 2014CK178
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
23-JUN-14
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
18-JUN-14
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. 27584
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
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).
A 7yr FS 29.1kg Golden Doodle with a previous history of immune mediate thrombocytopenia and episodic diarrhoea of unknown origin, was treated with Advantage II Extra large dog for the first time on June 18th. The product was applied to the skin along the dorsum.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
golden doodle (golden retreiver x poodle)
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
64
lbs
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
- Nervous and Muscular Systems
- Symptom - Abnormal posture
- General
- Symptom - Pacing
- Symptom - Vocalizing
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
Later that evening, the dog had a hunched posture. At 2am, the dog started vomiting, pacing and crying (vocalizing). At 3am the owner bathed the dog. On june 19th, the dog continued to vomit immediately after eating. 48 hours after initial product application, the dog was recovered. No medical treatment was required. The dog was not examined by a veterinarian.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here