Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-0115
2. Registrant Information.
Registrant Reference Number: 2013CK165
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.
26-NOV-13
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
14-NOV-13
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: Advantage (unknown size)
7. b) Type of formulation.
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 14-Nov-2013, a 1 year old, spayed, female, Domestic Shorthair feline, of unknown weight, in unknown condition, with fleas, was administered 1 tube of Advantage (dog -unspecified) (Imidacloprid) 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
Cat / Chat
3. Breed
Domestic short hair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1
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
<=30 min / <=30 min
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Specify - exhibited distress
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
Unknown/Inconnu
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
Immediately post application the cat exhibited distress. Approximately one hour later distress resolved and the cat was overly affectionate toward the owner (behavioral change).On 18-Nov-2013 the cat exhibited pruritus. No treatments or diagnostics were performed. The status of the cat is unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
GDS comment: Distress may be a behavioural response to the product sensation/smell within this short time to onset. Generalized pruritus however is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Duration to onset time too long. Signs may be linked with other etiologies. Overall, a relation to the product is due to different signs and courses unclassifiable.