Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-3677
2. Registrant Information.
Registrant Reference Number: 2018CP057
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.
07-MAY-18
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
08-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. 29780
PMRA Submission No.
EPA Registration No.
Product Name: K9advantixII 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).
on April 8 2018 , a 19.5 kg, 8 year old female neutered canine wheaten terrier with concomitant medical condition of Lyme disease , was applied one tube K9advantixII large dog once topically by the owner;
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
Irish Soft-coated Wheaten Terrier
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
19.5
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
- Symptom - Hair loss
- Symptom - Erythema
- Symptom - Other
- Specify - Application site self trauma
- General
- Symptom - Abnormal behaviour
- Nervous and Muscular Systems
- General
- Symptom - Biting
- Specify - biting at application site
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?
Unknown
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
3 hours after application, the dog had application site itching, application site hair loss, application site erythema , was biting at application site and was shaking her head; dog was prescribed topical vitamin E; unknown outcome
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. itching, erythema and hair loss may occur in sensitive dog, would not expect application site biting directly related to product. However, sign may be associated with reported application site itching. Head shaking is an unspecific sign. However, may be a consequence of the uncomfortable feeling caused by the applied product. Considering short time to onset and application site involvement, a product connection is deemed to be possible.