Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-5932
2. Registrant Information.
Registrant Reference Number: 2018RB130
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.
11-JUL-18
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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
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 the pet owner applied K9 Advantix II extra large to their 9 year old, 42.7 kg, Labrador Retriever.
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
Labrador Retriever
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
42.7
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Skin
- Symptom - Other
- Specify - Application site flaky skin
- Symptom - Dry skin
- Symptom - Irritated skin
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
Two days after application the dog developed flaky skin, dry skin, and irritated skin along the back at the application site. The dog was seen by the veterinarian and prescribed topagen to apply to the areas. The dog recovered an unknown time later.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
B - Possible
Application site irritation likely reflects discomfort caused by the applied product. Would not expect flaky and dry skin development directly related to product, however, likely dog scratched at site and caused skin lesions by self-trauma. Pruritus was not reported, however considering application site involvement and consistent time to onset, a product connection is deemed to be possible.