Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-4077
2. Registrant Information.
Registrant Reference Number: 2015KP104
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Bvd. East
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
20-JUL-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. 11556-135
Product Name: k9 advantix 55
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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).
On an unspecified date in approximately January 2010, a 12 year old, 70 pound, neutered, female, German Shepherd Dog canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix 55 (Imidacloprid - Permethrin) topically by the owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Dog / Chien
3. Breed
German Shepherd
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
70
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Lethargy
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
One day post application, the dog exhibited lethargy. The dog recovered the next day. On 12-Jan-2010, the dog died. No necropsy was performed. No more information is expected. 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
Lethargy is unspecific sign and may have numerous other causes. Death is not expected after product application. Though unknown, time to onset is over one day for death, therefore allergic/anaphylactic reaction can be ruled out. No necropsy done. Other causes more probable in this geriatric dog. Time for reporting is very long (5 years), and was probably concomitant to reporting of the recent event occurring on 31 May 2015 in another dog with another product. Considering all aspects, product relation is deemed to be unlikely.