Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-5229
2. Registrant Information.
Registrant Reference Number: 2017MA073
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.
31-MAY-17
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
31-MAY-17
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. 29780
PMRA Submission No.
EPA Registration No.
Product Name: K9advantix II large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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).
Owner applied a dose of K9 Advantix II for large dog to a 6yr 9.53kg dog (dose too high).
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
Chinese Crested dog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
9.53
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Paresthesia
- Symptom - Itchy skin
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
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?
Other / Autre
specify Unknown
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On Mai 19 an owner applied a dose of K9 Advantix II for large dog to a 6yr 9.53kg male Chinese crested dog. On Mai 18 the dog got a leptospirosis vaccine in the left hip.
On May 20 the dog had paresthesia and itching at the application site despite 2 baths (type of shampoo unknown)
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
A - Probable
Reported application site paresthesia and itching most likely reflect local dermal sensitivity to the product. Considering consistent time to onset, a product connection is probable.