Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-0148
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2020-US0060247 (Report 678455)
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-NOV-20
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. 11556-151
Product Name: advantageII small cat
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Other (specify)
spot-on
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4
Units: 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 23-Oct-2020, an 18 month old, 2.2 pound, intact, male, Unknown Breed (Rabbit), in poor condition, with concomitant medical conditions of fleas, ear mites, anorexia and weight loss, was seen by the veterinarian and administered .2 ml of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically, an unknown dose of Baytril (enrofloxacin) Antibacterial Injectable Solution 2.27% For Dogs Only (Enrofloxacin) subcutaneously, fluids subcutaneously, .2 ml of ivermectin subcutaneously and an unknown dose of Capstar (nitenpyram) orally by the attending vet. These medications were administered off label.
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
Other / Autre
specify Rabbit
3. Breed
Unknown
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1.5
7. Weight (provide a range if necessary )
0.998
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
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
An unspecified time later, in Oct 2020, the rabbit died. No necropsy was performed.
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
This is an off-label use of product (Unauthorized species). Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. No signs of allergy/anaphylactic reaction are reported. Additionally, this animal with poor health status had concomitant anorexia and weight loss. Other unrelated causes must be considered in this case. Considering the product profile, product involvement is deemed rather unlikely, however due to some information missing (no necropsy report) and time to onset is unknown. Product relation is considered as unassessable.