Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-8168
2. Registrant Information.
Registrant Reference Number: 2017CP373
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.
23-NOV-17
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
11-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 7 2017 , an 5 kg, 8 year old male neutered feline DMH with no concomitant medical condition was applied one tube advantageII large cat once topically by the owner.
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 Medium Hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
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
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- 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 November 7 2017 , an 5 kg, 8 year old male neutered feline DMH with no concomitant medical condition was applied one tube advantageII large cat once topically by the owner ; three day after application, cat was had application site alopecia , application site dermatitis and focal dermatitis on the lumbar area , cat was examined by a veterinarian on November 10 and treated with topical Douxo mousse; unknown outcome
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
O - Unclassifiable/unassessable
In individual cases, dermal reactions at the application site are possible in animals that are particular sensitive. Dermatitis on other than the application site is not anticipated with topical product administration. If any, skin reaction would be localized at the application site. Time to onset is short for application site disorders and long for dermatitis. Considering all aspects, product relation is unassessable.