Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-6277
2. Registrant Information.
Registrant Reference Number: 2017BS012
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.
02-MAY-17
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
18-JAN-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).
Owner has been applying monthly since Jan 17th, 2017 with the last dose give on April 29th to Bruiser who is a 16 month old, male, Australian Cattle Dog. Advantage II XL was applied in multiple spots along the dorsal midline.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Australian Cattle Dog
4. Number of animals affected
1
5. Sex
Male
Female
6. Age (provide a range if necessary )
1.25
7. Weight (provide a range if necessary )
36.8
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Erythema
- Symptom - Pruritus
- General
- Symptom - Other
- Specify - swollen tail
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Recvrd resid.effects/Rétabli séquelles
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
The following day after application of advantage II xl, erythema develops, the tail swells and has pruritus. The erythema disappears by the next day but on examination by veterinarian on May 5th, the tail was still swollen. The dog is experiencing pruritus so the dog is administered 50mg of Benedryl at night by owner. The veterinarian suspects some allergies and not related to the advantage II.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here