Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-3626
2. Registrant Information.
Registrant Reference Number: 2018RB101
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.
16-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
15-JUN-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.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: K9advantixII pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 June 15, 2018 the pet owner applid an unknown dose of K9 Advantix II to their 18 month old Golden Retriever.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
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
Unknown
6. Age (provide a range if necessary )
1.5
7. Weight (provide a range if necessary )
Unknown
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
- Nervous and Muscular Systems
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
Several hours after application the dog had lost the use of its hind end, had vomited, and was not as responsive as usual. The dog was seen by a veterinarian and was found to have returned almost to normal, and was prescribed vanectyl P and Benadryl. The outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here
O - Unclassifiable/unassessable
Reported hind limb paralysis is not anticipated with appropriate topical product administration as inconsistent with pharmaco-toxicological product profile. Other causes should be considered, e.g. behavioural response to uncomfortable feeling caused by applied product. Vomiting is an unspecific sign and may have numerous other causes. No potential oral uptake reported. Not as responsive as usual is likely a consequence of reported signs. Though time to onset is consistent, considering all aspects, a product connection is unassessable.