Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-4681
2. Registrant Information.
Registrant Reference Number: 2014CK111
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.
01-MAY-14
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
21-APR-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. 27660
PMRA Submission No.
EPA Registration No.
Product Name: K9 Advantix 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).
10yr FS Australian cattle dog (50.9lbs) was treated with k9 Advantix 55 topically on April 20th, 2014. The product was applied in 4 spots down the back.
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
australian cattle dog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
50.9
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Paresthesia
- Symptom - Red skin
- Symptom - Dermatitis
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
On april 21st, th eowner reported that the skin was twitchy and the dog was pruritic. The owner bathed the dog. On april 22nd, the owner reported that the dog was sensitive to touch and the application sites were red. The DVM recommended cortisone cream BID for 2 days. On april 24th, the owner reported that the application sites were red and irritated (dermatitis). The dog was examined later that day and the DVM noted that the dog was pruritic and the application sites were red. he dispensed benadryl and vanectyl P. On april 25th the owner reported that the dog was still pruritic.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here