Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-1751
2. Registrant Information.
Registrant Reference Number: 2014CK101
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-APR-14
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 .44 %
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 an unspecified date in 2011, a 13 year old, female, Schnauzer (Miniature) canine of unknown weight, in good condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid- Permethrin-Pyriproxyfen) once 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 schanauzer
4. Number of animals affected
1
5. Sex
Female
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?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Nervous and Muscular Systems
- Symptom - Other
- Specify - vertigo
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Yes
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
The following day the canine had difficulty walking(ataxia) and nystagmus. The owner bathed the canine with a liquid dish soap and took her to a veterinarian who examined her and diagnosed her with vertigo from an unknown cause. She was treated with an unspecified steroid by an unknown route. On an unspecified date the clinical signs resolved.On an unspecified date in 2013 the canine died from urinary bladder cancer. 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
Even though more expected after oral ingestion, permethrin has the potential to cause slight neurological disorders (e.g. ataxia) in particular susceptible animals. But nystagmus and vertigo are not expected after product application as inconsistent with pharmaco-toxicological product profile. Although consistent time to onset, other neurological causes are more probable. Death is not expected after product application. Time to onset very long (2 years), therefore allergic/anaphylactic reaction unlikely. Death likely related to the concomitant urinary neoplasia. Considering all aspects, product relation is deemed to be unlikely.