Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-0180
2. Registrant Information.
Registrant Reference Number: 2014CK398
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.
28-OCT-14
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
28-OCT-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. 27582
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
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).
A pitbullxboxer, 13months old, weight 29.8kg F intact. The doge was treated with Advantage II large dog on october 28th 2014.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
crossbreed
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.2
7. Weight (provide a range if necessary )
29.8
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
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Inflammation of the skin
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
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
The dog developed application site inflammation the same day and vomited. The dog presented to a veterinarian on October 29th, 2014. The application site inflammation and vomiting had resolved at that time, however, the owner reported that the dog had diarrhea. the veterinarian prescribed metronidazole for 5 days. On november 7th, the pet owner called Bayer to report that the dog was vomiting again. No further information is currently available.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here