Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-4034
2. Registrant Information.
Registrant Reference Number: 2018BS007
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-MAY-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
20-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. 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).
K9 advantix II XL was applied along the dorsal midline to x a 2 yr old, F/S, Golden Ret weighing 30kgs on April 19/18.
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
Golden Retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
30
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Symptom - Pacing
- Skin
- Symptom - Pruritus
- Specify - self trauma
- Nervous and Muscular Systems
- Symptom - Shaking
- Symptom - Anxiety
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
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
On April 20/18 x was panicked, anxious, pacing, scratching, itching, restless, shaking and snapping at hindend. Symptoms lasted 24 hours and x fully recovered 24 hours later on April 21/18. Clinic recommended using Vit E for next dose.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
B - Possible
Though would not expect generalized skin disorders after topical application, reported scratching, itching, snapping along with pacing and restlessness may reflect paresthesia caused by permethrin. Shaking is not expected after product application. Reported panic, anxious and shaking are very unspecific, however may be a consequence of the uncomfortable feeling caused by the applied product. Considering consistent time to onset, a product relation cannot be excluded and is deemed to be possible.