Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-0020
2. Registrant Information.
Registrant Reference Number: 2017RB215
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.
14-NOV-17
5. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
6. Date incident was first observed.
Unknown
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.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: Advantage II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 an unknown date the pet owner applied Advantage II for cats (unspecified dose) to their barn cat (age, weight, sex, breed not given).
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Crossbred
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Other
- Specify - Application site necrosis
- Symptom - Other
- Specify - Application site excoriation
- Symptom - Other
- Specify - Application site malodourous area
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
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 an unknown date the pet owner applied Advantage II for cats (unspecified dose) to their barn cat (age, weight, sex, breed not given). At an unknown time after application the skin at the application site sloughed off and there was a necrotic, malodourous area. The cat was seen at a veterinary clinic for unspecified treatment. Requested further information from veterinarian but none has been received.
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 particularly sensitive. But would not expect the reported application site disorders directly related to the product. However, likely cat scratched at site and caused skin lesions by self-trauma. Self-trauma may have aggravated the application site reaction. Application site malodour may be associated with the necrosis. Time to onset is unknown. A product relation is considered unassessable.