Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-6331
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2022_058044
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 1919 Minnesota Court, Suite 401
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5N 0C9
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
15-AUG-22
5. Location of incident.
Country: UNITED STATES
Prov / State: MINNESOTA
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. 11556-155
Product Name: Seresto Small Dog Collar
- Active Ingredient(s)
- FLUMETHRIN
- Guarantee/concentration 4.5 %
- IMIDACLOPRID
- Guarantee/concentration 10 %
7. b) Type of formulation.
Other (specify)
collar
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Other Units: collar
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 15 Aug 2022, an animal owner contacted Elanco regarding a potential adverse event with using Seresto Small Dog (Imidacloprid, Flumethrin) on their dog and reported the following: On approximately 16 May 2022, a dog was applied 1 collar of Seresto Small Dog (Imidacloprid, Flumethrin) topically by animal owner for flea/tick control. It was unknown if product was used correctly. Concomitant products were unknown.
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
Dog / Chien
3. Breed
Unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Loss of appetite
- Liver
- Symptom - Elevated liver enzymes
- General
- Symptom - Neoplasia
- Symptom - Cancer
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
On an unknown date post application, the female canine, of unknown signalment and condition, with no known concomitant medical conditions, was showing no symptoms but was a bit fussy about eating (loss of appetite). On an unknown date in Jun2022, the dog was evaluated by the veterinarian and the checkup revealed a low red blood cell count (anemia). The liver enzymes were high. And she was too diagnosed with cancer. Leukemia was the final diagnosis. The dog passed away on 22 Jul 2022.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here