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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-0364
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2021_036851
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.
10-NOV-215. Location of incident.
Country: UNITED STATES
Prov / State: FLORIDA
6. Date incident was first observed.
24-SEP-21Product 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. 11556-125
Product Name: Advantage II Medium Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
- IMIDACLOPRID
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1Units: mL
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 10 Nov 2021 an animal owner contacted Elanco regarding a perceived lack of efficacy and death involving Advantage II Medium Dog in a dogs and reported the following: On an unknown date, a dog in unknown condition, with the concomitant medical condition of fleas, were administered 1 tube of Advantage II (imidacloprid+pyriproxyfen) Medium dog, topically, by the animal owner for flea treatment and control. The product was used intermittently (off label) (treatment program not respected). Concomitant products include dish soap and vinegar.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
Unknown
4. Number of animals affected
1
5. Sex
Unknown
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?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Parasitism
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 approximately 01 May 2021 the dog, of an unknown signalment, exhibited fleas. On 11 May 2021 and 13 Jun 2021 the dog received 1 tube of Advantage II Medium dog for flea control. No Advantage II was applied in Jul 2021 (animal owner's email started Jun; however, captured as Jul due to email contradiction). On 14 Aug 2021, fleas were noted again, and Advantage II Medium dog was restarted (1 tube applied to dog topically). At this time the animal owner indicated a decrease in product efficacy due to the number of flea being seen. On 16 Sep 2021, the two dogs were bathed in dish soap and vinegar. On 17 Sep 2021, lots of fleas were noted, and Advantage II Medium Dog was applied to the dog (tube each, topically). The yard was sprayed. On 24 Sep 2021, the dog died. No additional information was provided regarding the dog's death.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
