Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-2446
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2021-US0010569 (Report 692173)
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.
25-MAR-21
5. Location of incident.
Country: UNITED STATES
Prov / State: VIRGINIA
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 large dog
- 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 an unknown date in approximately 2020, a 4.5 year old, 140 pound, intact, male, Crossbred Canine, in unknown condition, with no known concomitant medical conditions, had a Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner.
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
Dog / Chien
3. Breed
Crossbred
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
4.5
7. Weight (provide a range if necessary )
63.503
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Aggressive behaviour
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
Euthanised / Euthanasie
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 in approximately 2020, the dog began biting and attacking other animals and people.
On an unknown date in approximately 2020, the dog was shot by the owner and died immediately. The dog was not examined by a veterinarian and no known necropsy was performed.
No more information is expected. This case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
O - Unclassifiable/unassessable
Reported biting and aggression are unspecific signs and may have numerous other causes. Time to onset unknown. Other causes should be considered. Further reported fatal outcome of death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. In this case death is not related to product as animal died due to being shot by the owner. No necropsy was performed. Considering all aspects, a product relation is unassessable.