Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-0511
2. Registrant Information.
Registrant Reference Number: 2015CK019
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.
19-JAN-15
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. Unknown
Product Name: k9 advantix II unknown
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 and unspecified date in 2013, a 17 year old, unknown weight, neutered, male, Schnauzer (Miniature) canine, in unknown condition, with no known concomitant medical conditions was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
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 )
17
7. Weight (provide a range if necessary )
Unknown
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
Unknown / Inconnu
11. List all symptoms
System
- Cardiovascular System
- Symptom - Other
- Specify - congestive heart failure
12. How long did the symptoms last?
Unknown / Inconnu
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
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 an unspecified date in 2013 the dog was diagnosed wiith congestive heart failure. The dog was placed on an unknown furosemide treatment. The dog continued to decline an died on an unknown date in 2013. It is unknown if a 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
Congestive heart failure and subsequently reported death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Reliability questionable due to very low level of information (weight, medical history and time to onset unknown - necropsy not available). Other etiologies more probable. No signs of allergy/anaphylactic reactioneported. Death may be a consequence of congestive heart failure and advanced age. Even though time to onset unknown, occurrence of death within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Considering all aspects, product connection deemed to be unlikely.