Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2524
2. Registrant Information.
Registrant Reference Number: 2018CK012
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.
19-APR-18
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
15-APR-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: 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).
5yr mn crossbreed dog 7.1kg was treated with 1 tube of k9 advantix II medium on april 15th.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Crossbred (Dog)
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
7.1
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Skin
- Symptom - Itchy skin
- Specify - Application site itching
- Symptom - Hair loss
- Specify - Application site hair loss
- Symptom - Red skin
- Specify - Application site reddening
- Symptom - Lesion
- Specify - Application site lesion
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
later in the evening, redness was noted at the application sites. the next day the dog had intense itching at the application sites. A skin lesion developed with hairloss at the application sites. The dog was treated wtih antiseptic, clavaseptin and benadryl
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
B - Possible
Whereas skin reaction at application site, e.g. redness, itching and hair loss may occur in sensitive dog, would not expect application site skin lesion directly related to product. However, may be linked to scratching at application site which caused sign by self-trauma. Overall, considering consistent time to onset, a product connection is deemed to be possible.