Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-1206
2. Registrant Information.
Registrant Reference Number: 2012BS090 - US0026545
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-12
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. 11556-134
Product Name: K9advantix100
- 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.
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).
In 2004 1 tube of K9 Advantix 100 was applied to the dorsal midline by owner to a 8 year old, 100lb,M/N German Shepherd dog with no known concomitant medical conditions
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
Other
2. Type of animal affected
Dog / Chien
3. Breed
German Shepherd
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
100
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Application of K9 Advantix 100 was given in 2004 and within 1 hour dog was lethargic which lasted about 10 hours and resolved without intervention. In 2007, dog passed away at age of 11 due to bloating. No other information is available.
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 multiple potential other causes in animal considering short onset time may represent behavioural response to product sensation. However bloat and death not expected after application. Time of onset 3 years extremely long. Death likely related to advanced age and/or gastrointestinal disorder (bloat). Product relation unlikley.