Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-0969
2. Registrant Information.
Registrant Reference Number: 35432
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.
24-FEB-21
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
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. 27586
PMRA Submission No.
EPA Registration No.
Product Name: advantage II large cat
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
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 an unknown date in Dec-2020, a 4 year old, 6.6 kg, female spayed Domestic Medium Hair in good condition with no concomitant medical conditions was administered one ADVANTAGE II 4 X 0.8 ML LARGE CAT, KP096L (-), by Animal owner. The product was used according to label (Yes).
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
Female
6. Age (provide a range if necessary )
4
7. Weight (provide a range if necessary )
6.6
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Itchy skin
- Symptom - Dermatitis
- Symptom - Erythema
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
2 weeks after application the cat experienced hair loss at the application site between the shoulder blades, was itchy, and began to scratch at the application site. The application site became raw.
On 30 Jan 2021 the cat was seen by a veterinarian who noted localized milliary and bacterial dermatitis between the shoulder blades at the application site and erythema at the application site. The veterinarian deemed this to be a contact alopecia as a result of Advantage II. Skin cytology was performed and the cat was administered Convenia (cefovecin sodium sterile injectable lyophile).
On 17 Feb 2021 the cat was re- evaluated by the veterinarian who observed the area was starting to heal and hair was growing back. The outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here