Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-1231
2. Registrant Information.
Registrant Reference Number: 2012BS114 - US0024195
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
17-JUL-12
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
30-APR-11
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.
PMRA Submission No.
EPA Registration No. 11556-128
Product Name: advantage II Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Liquid
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 approx Sept 1/2010 1 tube of Advantag II sm dog was applied to a 12yr old, 9lb, spayed female Yorkshire Terrier in fair condition on the dorsal midline by owner.
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
Other
2. Type of animal affected
Dog / Chien
3. Breed
Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
9
lbs
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
>6 mos / > 6 mois
11. List all symptoms
System
- Cardiovascular System
- Symptom - Other
- Specify - heart disease
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
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 Apr 30/2011 dog died from heart disease. No more information expected. Owner called Bayer to report reaction on current dog in household and mentioned this dog. Dog had history of heart disease.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Level of information low and inconsistent with pharmaco-toxicological product profile. On set over 6 months. Relation to product can be excluded.