Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-4499
2. Registrant Information.
Registrant Reference Number: 2013AM242
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.
13-AUG-13
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
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.
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).
One vial of K9 Advantix II extra large dog was applied topically by the owner to one spot on 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
unknown
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
16
7. Weight (provide a range if necessary )
80
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
- Gastrointestinal System
- Symptom - Weight loss
- Symptom - Loss of appetite
- Specify - innapetence
12. How long did the symptoms last?
Persisted until death
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 approximately 01-Apr-2013, a 16 year old, 80 pound, neutered, male, Mixed Breed canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) once topically by the owner. On an unknown date in Apr2013 the dog became inappetent and losing weight. On an unknown date in Apr2013 the dog died at home. No necropsy was performed. No further information is expected. This case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Death is not expected in dogs after product application, as inconsistent with pharmaco-toxicological product profile. The patient was very geriatric (16 years) and developed inappetence and weight loss after an unknown time following product application. No necropsy was performed. The intent of the owners call at Bayer was not to report the death of the animal but to ask for information concerning active tick infestation. In conclusion, a correlation between the product application and the death of this dog is assessed as unlikely.