Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-0022
2. Registrant Information.
Registrant Reference Number: 2017RB217
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
17-NOV-17
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
15-NOV-17
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. 27586
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Large Cat
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
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).
On November 15, 2017 the pet owner applied Advantage II large cat to their 5.5 kg, female neutered, 5 year old domestic short hair cat.
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
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
5.5
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Other
- Specify - Application site skin scaling
- Symptom - Red skin
- Symptom - Irritated skin
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 November 15, 2017 the pet owner applied Advantage II large cat to their 5.5 kg, female neutered, 5 year old domestic short hair cat. Less than 24 hours after application the cat developed redness at the application site, irritation at the application site, and scaly skin at the application site and was seen by a veterinarian. The cat was treated with systemic antibiotics and an antihistamine injection.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
A - Probable
A dermal reaction at the application site in a particular sensitive animal is expected. Would not expect application site scaling directly related to the product however, likely cat scratched/ licked at site and caused skin lesions by self-trauma. Self-trauma may have aggravated the application site reaction. Time to onset is short. Finally, a product relation is probable.