Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-7217
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2023_056381
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.
18-OCT-23
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. 11556-155
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 18 Oct 2023, an animal owner posted online regarding an adverse event involving Seresto Large Dog Collar in their dog and reported the following. On an unknown date, a dog had a Seresto Large Dog Collar (Imidacloprid, Flumethrin) applied topically by animal owner for an unknown reason. No information is available on if the collar was used correctly and if any concomitant medicines were used.
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
Bulldog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Ataxia
- Symptom - Collapse
- General
- Symptom - Polydipsia
- Specify - Increased water intake
- Symptom - Listless
- Gastrointestinal System
- Symptom - Loss of appetite
- Nervous and Muscular Systems
- General
- Symptom - Loss of balance
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
1
Day(s) / Jour(s)
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
Two days after application of the collar, the 6-year-old, unknown weight, female (unknown reproductive status), Bulldog dog, in unknown condition, with unknown concomitant medical conditions, started to lose its balance (ataxia) and collapsed on floor. The following day the signs persisted and it is unknown if the collar was removed. The dog then refused to eat (loss of appetite) and began drinking more water (increased water intake). The dog was seen by a veterinarian and was diagnosed with kidney failure. An intravenous catheter was placed and the pet owner gave unspecified medications at home. The dog initially improved for a few days, then the dogs condition declined and was taken to a different veterinary clinic. The dog was administered intravenous fluids, and hospitalized overnight, then discharged to the pet owner. The dog then experienced vomiting, became listless, and would sleep all day. Nine days after the product was applied, 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