Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-1569
2. Registrant Information.
Registrant Reference Number: 2013AM060 - US0009781
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.
01-SEP-12
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
01-SEP-12
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. 11556-144
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.
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 approximately Sept. 1, 2012, a 9.5 year old, approximately 67 pound, male, German Shepherd crossbred canine, in good condition, with no known medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog once topically by the 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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
German Shepherd Cross
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
9.5
7. Weight (provide a range if necessary )
67
lbs
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
- General
- Symptom - Death
- Symptom - Abnormal behaviour
- Eye
- Symptom - Glazed eye
- Specify - eyes looked glassy
- Nervous and Muscular Systems
- Symptom - Loss of coordination
- Specify - tried to jump on owner but fell over
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
An undetermined amount of time later, the dog was acting abnormal and when he tried to jump up on the owner, he fell over. The dog's eyes also looked glassy at that time. A few days later, the dog was found deceased in the woods on the property.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Death not expected after product application as inconsistent with pharmaco-toxicological product profile. Other etiologies are more probable. Behavioural disorders shortly after product application may be consequence of uncomfortable feeling caused by applied product. However, unlikely to occur days or weeks after product application. Glassy eyes, falling and fatal outcome not expected, as inconsistent with pharmaco-toxicological product profile.