Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-4500
2. Registrant Information.
Registrant Reference Number: 2013AM243
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
Miniature schnauzer
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
13
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
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 16-Apr-2013, a 13 year old, male, Schnauzer (Miniature) canine of unknown weight, in fair condition with a history of cardiac failure and treated with an unknown dose of oral lasix and an unknown cardiac failure medication, was administered a partial amount of K9 Advantix II Extra Large Dog (Imidacloprid- Permethrin-Pyriproxyfen) once topically by the owner. On approximately 13May2013 the canine was diagnosed with an abdominal neoplasia by the veterinarian. On an unspecified date the canine died. No necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Limited details were provided for this event. Neoplasia and death is not expected in dogs after product application, as inconsistent with pharmaco-toxicological product profile. Reliability is questionable due to very low level of information (unspecified neoplasia, time to onset unknown for death, necropsy not available). Other etiologies are more probable (e.g. cancer, heart failure), in particular as concomitant conditions were present prior to product use in this elderly dog. Considering all aspects, product connection deemed to be unlikely.