Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6609
2. Registrant Information.
Registrant Reference Number: 2018EB206
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-AUG-18
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
30-JUL-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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
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.
5
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 3 year old, 52 kg female spayed Alaskan malamute. In July 2018, the patient had 1 vial of Advantage Multi 100 and 1 vial of Advantage Multi 20 applied. The patient had 1 vial of K9 Advantix II XL dog with 1 vial of K9 Advantix II Medium dog applied.
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
Alaskan Malamute
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
52
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
Unknown / Inconnu
11. List all symptoms
System
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
The interval of time between the time that the vials of Advantage Multi and K9 Advantix II is unknown. The patient was seen on July 30, and had some hair loss on the neck area (application site). The patient was not treated. 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
B - Possible
Reported application site hair loss may reflect local dermal sensitivity to the product. Though time to onset is unknown, considering application site involvement, a product connection is deemed to be possible.