Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-1522
2. Registrant Information.
Registrant Reference Number: 33294
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.
20-MAY-20
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
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. 29778
PMRA Submission No.
EPA Registration No.
Product Name: k9 advantix II medium dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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 15-May-2020, a 3 year old, 5.5 kg, male neutered Shih Tzu in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 1.0 ML MED DOG, (-), 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
Dog / Chien
3. Breed
shih tzu
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
5.5
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Itchy skin
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
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
Less than 6 hours after application, the patient had generalised pruritus, was very itchy and was biting the base of his tail. The patient was bathed with dish soap on 17-May-2020 and again on 18-May-2020. The pet owner also applied a cream (it is unknow which cream was used). On 19-May-2020, the pet owner called the clinic to report that the patient was scratching and biting himself, the skin seemed normal and intact. The pet owner declined an exam by a veterinarian. The pet owner bathed the patient with dish soap. The outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here