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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-3000
2. Registrant Information.
Registrant Reference Number: 2014CK222
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-JUL-145. 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. 11556-143
Product Name: K9 Advantix 55
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- IMIDACLOPRID
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5Units: 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 an unknown date in Sept-2008, a 16 year old, 42 pound, neutered male, Standard Poodle canine, in good condition, with concomitant medical conditions of hearing loss and blindness, was administered a partial tube of K9 Advantix 55 (Imidacloprid - Permethrin) topically by the owner. This is an off label use of the product.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
standard poodle
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
16
7. Weight (provide a range if necessary )
42
lbs
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Lethargy
12. How long did the symptoms last?
Persisted until death
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
3 hours after product application the dog developed lethargy which lasted 24 hours then resolved. The product was not applied again.On an unknown date in Feb 2009 the dog passed away. No necropsy was performed.Note: The intent of the phone call to Bayer Animal Health was not to report the death of this patient but to inquire about the use of the product on another pet in the home. The death of the patient was deemed due to his geriatric condition and not product related.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Lethargy is an unspecific sign and may have multiple potential other causes in a dog. However, considering consistent time to onset, it may represent a behavioural response to the product sensation. Death is not expected after product application. Time to onset very long, therefore allergic/anaphylactic reaction can be ruled out. The owner did not call to report the death of this patient but to inquire about the use of the product on another pet in the home. Death likely related to a concomitant medical status or to old age of the dog. Considering all aspects, product relation is deemed to be unlikely.
