Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-6228
2. Registrant Information.
Registrant Reference Number: 2013CK093
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.
29-OCT-13
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
28-APR-13
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. 25131
PMRA Submission No.
EPA Registration No.
Product Name: Advantage 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).
Owner applied Advantage on April 28th and monthly till September 28th.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Chocolate labrador
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
Unknown
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
<=30 min / <=30 min
11. List all symptoms
System
- Skin
- Symptom - Erythema
- Symptom - Pruritus
- Nervous and Muscular Systems
- General
- Symptom - Licking
- Symptom - Biting
- Specify - biting toes
12. How long did the symptoms last?
Unknown / Inconnu
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
Not recovered / Non 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
After each application, the dog almost immediately appeared uncomfortable (restless). Within a couple of hours, the dog became pruritic (frequent grooming) with the affected area appearing to spread from the application site across the body to the toes over the 3-4 days following application. Within a couple of days post application, the dogs skin appeared red (visible over the belly). Towards the end of the month, the dog appeared less itchy/red, however, symptoms were not completely resolved prior to the next application (still frequently grooming, especially licking/biting toes).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The owner reported that this dog has also been investigated for allergic skin disease due to pruritus that has been apparent in previous years. The dog has not received Advantage prior to April 28 2013. The dog currently receives no medication and does not have any additional medical problems (other than possible allergic skin disease)