Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-4219
2. Registrant Information.
Registrant Reference Number: 36738
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.
09-AUG-21
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
02-AUG-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. 29779
PMRA Submission No.
EPA Registration No.
Product Name: k9 advantix II extra large 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.
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).
On 28-Jul-2021, a 8 year old, 43.7 kg, male neutered American Staffordshire Terrier in good condition with no concomitant medical conditions was administered one K9 Advantix II II 6 X 4.0 ML EX LGE DOG, (-). The product was used according to label (Yes). This was the first use of this product. The dog also received an unknown dose of cartrophen by subcutaneous injection. The dog has been receiving this medication each month.
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
American Staffordshire Terrier
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
43.7
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
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Erythema
- Symptom - Dermatitis
- Symptom - Lesion
- Symptom - Inflammation of the skin
- Symptom - Other
- Specify - Puss
- Symptom - Other
- Specify - Purulent secretions
- Symptom - Other
- Specify - Thickening of skin
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 2 Aug 2021 the dog experienced pruritus, erythema, and pus at application site. The pet owner has applied Polysporin 3 times per day.
On 3 Aug 2021 the pet owner applied Polysporin 3 times per day.
On 4 Aug 2021 the pet owner applied Polysporin 3 times per day.
On 5 Aug 2021 the dog was seen by a veterinarian and was found to have a 5 cm lesion neck, inflammation and thickening of skin on 7 cm, and purulent secretions. The dog was treated with cefaseptin for 10 days.
On 9 Aug 2021 there was no improvement. The veterinarian planned to perform a culture and antibiogram. The outcome is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here