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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-2129
2. Registrant Information.
Registrant Reference Number: 2017BS007
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.
17-APR-175. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
12-MAR-17Product 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: k9 advantix II large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PERMETHRIN
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5Units: 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 Mar 12/17 and April 13/17, 1 tube of K9 advantix II Med to a 13kg, 4 year old, MN, Pug in 4 spots along the dorsal mid-line by pet owner.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
shih tzu
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
4
7. Weight (provide a range if necessary )
13
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- General
- Symptom - Discomfort
- Nervous and Muscular Systems
- Symptom - Muscle twitching
- Symptom - Shaking
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
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
Not recovered / Non 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
A few hours after application, owner noted that Moose seemed uncomfortable, his skin was twitching, and his muscles were shaking. She took him to an emergency clinic and he did not have a rash, DVM suspected back pain. The DVM dispensed Apoquel and methocarbamol at that time. The owner also have him a bath. When clinical signs did not resolve, owner took Moose to another DVM that dispensed tramadol and recommend a visit for acupuncture. Owner took Moose in for acupuncture, but a cold laser was recommended instead. She treated him with cold laser. His clinical signs improved. Caller reports that Moose was due to the next flea treatment on 4/13/17 and she called her DVM to ask about administration. Her DVM recommended administration again as the previous incident was not suspected to be an adverse reaction. Owner reports that 2 hours after the administration, Moose started having the same clinical signs. Owner was then told by a friend that it was likely paresthesia and to give diphenhydramine and apply Vitamin E. She has also given him a bath with Dawn dish soap.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
