Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-0048
2. Registrant Information.
Registrant Reference Number: 2017TH207
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.
22-SEP-17
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
Unknown
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.
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).
Product was applied to mother, not to puppies. Breeder uses large size product and splits it for smaller dogs.
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
Dog / Chien
3. Breed
Jack Russel
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.2
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Reproductive System
- Symptom - Birth defect
- Specify - limb deformity at birth
12. How long did the symptoms last?
Anticip. permanent/Permanence anticipée
13. Was medical treatment provided? Provide details in question 17.
No
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
In 2017 a pet owner treated a pregnant jack russel terrier with 1 ml of advantage II XL at least 2 times during pregnancy. On Aug 6 the dog whelped 3 puppies. 1 puppy was born with a shortened forelimb and only 3 toes on that paw.
Reproductive drop down menu is non-functional, unable to select birth defect for limb deformity
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here