Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-3300
2. Registrant Information.
Registrant Reference Number: 36384
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.
23-JUN-21
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
05-MAR-21
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. 29778
PMRA Submission No.
EPA Registration No.
Product Name: k9 advantix II medium dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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).
From Oct-2020 to May-2021a 0.83 year old, 6.2 kg, male Crossbred (Dog) in good condition with no concomitant medical conditions was administered one ADVANTAGE MULTI 20 (6 X 1.0 ML), (-), by Animal owner monthly. The product was used according to label (Yes). The dog was also administered one tube K9 Advantix II medium dog by animal owner monthly. The product was used according to label (Yes).
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
Crossbred dog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.83
7. Weight (provide a range if necessary )
6.2
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>6 mos <=1 yr / > 6 mois < = 1 an
10. Time between exposure and onset of symptoms
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- Liver
- Symptom - Elevated liver enzymes
- Symptom - Other
- Specify - Elevated Bile acids
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
On 5 Mar 2021 the dog had a moderately elevated ALT.
On 10 Mar 2021 the dog had an elevated post bile acids test.
On 12 Apr 2021 bloodwork revealed a mildly elevated ALT.
On 31 May 2021 the dog had a moderately elevated ALT and a moderately elevated AST.
The pet owner suspects the elevated liver enzymes and bile acids are due to administration of advantage multi and K9 Advantix II. The veterinarian does not believe the products are responsible for the abnormal bloodwork and instead believes the dog has microvascular dysplasia. The outcome is unknown. Please see related case 36383 (same patient).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here