Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-1726
2. Registrant Information.
Registrant Reference Number: 2014CK76
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.
01-AUG-12
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. 11556-130
Product Name: Advantage 100
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
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).
On 01-Aug-2012, a 17 year old, 6 pound, spayed, female, domestic short hair feline, in poor condition, with no known concomitant medical conditions, was administered an unspecified amount of Advantage 100 Topical Solution (Imidacloprid) once topically off label by the owner. This product was labeled for canines
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
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
domestic shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
17
7. Weight (provide a range if necessary )
6
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
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Lethargy
- Symptom - Licking
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
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
Approximately 5 minutes post product application the cat licked the product and was lethargic.On 02-Aug-2012 the signs resolved. No medical intervention was sought.On about 31-Aug-2012 the cat passed away. No 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
The information regarding the death of the cat was casually provided during an inquiry. Reporting of occurrence one and a half year after last product application. Although sign is rather unspecific, lethargy may exceptionally occur in particular sensitive animals within this compatible time to onset. Sign stopped within 24 hours. Nevertheless, the cat died one month after last exposure which is not expected as inconsistent with pharmaco-toxicological product profile and experience. Chronology inconsistent. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. The cause of death of this geriatric cat is not described however most likely related to old age. Overall, a product relation can be excluded.