Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-7413
2. Registrant Information.
Registrant Reference Number: 2017CK170
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-NOV-17
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
15-NOV-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. 27584
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- 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).
3kg 16week male intact dmh treated with partial dose of advantage II XL on November 15th. started twitching 30 minutes later. (Unauthorised species- Dog product used on cat)
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
Cat / Chat
3. Breed
Domestic Medium Hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.30
7. Weight (provide a range if necessary )
3
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Muscle tremors
- Symptom - Recumbent
- Symptom - Muscle twitching
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
3kg 16week male intact dmh treated with partial dose of advantage II XL on November 15th. started twitching 30 minutes later. taken to emergency clinic - recumbent, tremors and twitches. treated with methocarbamol. responded well. bloodwork normal. twitches recurred at home so returned to veterinary clinic. responded well to methocarbamol. will be discharged later today. Another kitten also treated with Advantage II XL remains asymptomatic.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
B - Possible
Off label use as dog product used on cat. Neurological signs are not typically observed with appropriate topical product administration, however are possible with or administration of an overdose. Recumbency is not expected with appropriate product use however it may be associated with the reported neurological signs. Time to onset short. A product involvement is deemed to be possible.