Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-5714
2. Registrant Information.
Registrant Reference Number: 2018EB144
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.
18-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
27-MAY-18
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: K9advantixII 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).
The patient is a male neutered Yorkshire Terrier,1.5 years, 4.35 kg. On may 25th the pet owner applied 1 vial of K9 Advantix II medium dog.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1.5
7. Weight (provide a range if necessary )
4.35
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Ear
- Symptom - Other
- Specify - Otitis
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
Fully Recovered / Complètement rétabli
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
This is the first time the patient was receiving K9 Advantix II. Within the next 2 days the patient became itchy. The patient was seen on May 28th, the patient was scratching everywhere and developed an otitis. No bacteria or yeast found on the smear only inflammation. The patient was treated with prednisone. The patient was bathed. The outcome is recovered.
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
Reported itching is not expected to be generalized but rather be linked to the application site. Other causes should be considered, e.g. allergies. Otitis is not expected with appropriate topical product use. However, in this case may be associated with reported itching. Considering a bit long time to onset (2 days), a product connection is unassessable.