Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-0178
2. Registrant Information.
Registrant Reference Number: 2014CK396
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.
17-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. 25127
PMRA Submission No.
EPA Registration No.
Product Name: advantage 55
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 11yr FS 15.9kg cross breed dog was treated with Advantage 55 for the first time on October 17th 2014.
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
cross breed
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
15.9
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
- Skin
- Symptom - Pruritus
- Symptom - Rash
- Symptom - Lesion
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 began scratching at the application site later that night. On October 18th, the owner noted a rash at the appliction site. On october 27th ,the dog presented to the veterinary clinic. Numerous 1/2 cm round lesions were identified on the skin between shoulder blades towards the neck (application site). There was also a rash on the abdomen from the umbilicus to the inguinal region. The dog was bathed and treated with vanectyl P
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here