Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-5729
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2023_035671
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.
11-JUL-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 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 11 Jul 2023, an animal owner contacted Elanco to check the authenticity of a point of purchase for Seresto for her current pets and reported an adverse event with the use of a Seresto Small Dog (Imidacloprid, Flumethrin) collar for a dog which previously used the collar and reported the following: On an unknown date, a dog had 1 Seresto Small Dog collar placed around the neck by the animal owner for parasite prevention. It was unknown if the product was used correctly. It was unknown if concomitant products were administered.
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
Pomeranian
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
16
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Red skin
- Symptom - Rash
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
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
One day post collar application, the 16-year-old, unknown weight, unknown reproductive status, female, Pomeranian dog, in unknown condition, with no known concomitant medical conditions, exhibited application site reddening (red skin), application site rash and application site alopecia (hair loss). The collar was removed and the dog was bathed with a liquid dish soap. The dog was not examined by a veterinarian. On an unknown date, the dog fully recovered. On an unknown date, the dog, now 17-years-old, died. It was unknown if the dog was examined by a veterinarian. It was unknown if a necropsy examination was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here