Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-6236
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2021_023755
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
10-SEP-21
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. 11556-151
Product Name: Advantage II Small Cat
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
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 10 Sep 21 Elanco was contacted by an animal owner regarding a perceived lack of efficacy (reported in a separate case). During the course of the call, the owner mentioned an adverse event involving Advantage II Small Cat in an unknown male cat weighing approximately 3.628 kg. The owner stated that she used Advantage II Small Cat with this cat for years without incident.
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
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Unknown (Feline/cat)
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
3.6
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 yr / > 1 an
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
12. How long did the symptoms last?
Persisted until death
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
She commented that the cat lost weight before he died. The owner does not attribute the cat's death to product use. No additional information was provided. No additional information is expected, Elanco considers this case closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here