Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-1822
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2024_004908
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.
08-FEB-24
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
10-AUG-23
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 Large 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 08 Feb 2024, an animal owner contacted Elanco regarding a potential adverse event involving Seresto Large Dog (Imidacloprid, Flumethrin) collar. On 16 May 2023, one Seresto Large Dog (Imidacloprid, Flumethrin) collar was applied around the neck of a dog by the animal owner (misuse: overdose).
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
Dog / Chien
3. Breed
Schnauzer - Miniature
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
6.5
7. Weight (provide a range if necessary )
7.71
kg
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
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- Blood
- Symptom - Anemia
- Specify - Immune mediated haemolytic anaemia
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
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 10 Aug 2023, the 6.5 year old, 7.71 kg, female, neutered, Miniature Schnauzer canine, in unknown condition, with irritable bowel syndrome, was diagnosed with immune mediated hemolytic anemia. The dog was administered a whole blood transfusion by a veterinarian. On 15 Aug 2023, the dog died.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here