Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-4924
2. Registrant Information.
Registrant Reference Number: 2011TH063
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Road
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.
26-AUG-11
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
19-JUL-11
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. 27659
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix 100
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).
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
Golden Retriever
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
33.9
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
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
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
Owner applied K9 advantix to two dogs on July 10 2011. On July 19 the owners were drying the dog after swimming and noticed an area of dermatitis located between the shoulder blades. This area seemed to get worse over night. The dog was examined July 20 2011 and two areas of dermatitis were noted, one on the back of the neck and once between the shoulder blades. It is not known if these areas correspond to application sites. The dog was prescribed oral cephalexin and topical topagen to apply. The other dog was unaffected. Both dogs had been swimming frequently.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Moderate as treatment given