Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2264
2. Registrant Information.
Registrant Reference Number: CAN-ZZELANCO-CA2024_000487
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.
01-MAR-24
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
26-FEB-24
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. 27584
PMRA Submission No.
EPA Registration No.
Product Name: Advantage II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 01-Mar-2024, a clinic staff member contacted Elanco regarding a possible adverse reaction to Advantage II Extra Large Dog (Imidacloprid, Pyriproxyfen). On 26-Feb-2024, the pet owner applied a partial tube of Advantage II Extra Large Dog (Imidacloprid, Pyriproxyfen) to the cat (misuse species and intentional misuse).
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.33
7. Weight (provide a range if necessary )
2.11
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Ataxia
- Symptom - Difficulty getting up
- Renal System
- Symptom - Lack of control of urination
- Eye
- Symptom - Protrusion of the third eyelid
- Nervous and Muscular Systems
- Blood
- Symptom - Other
- Specify - Eosinopenia
- Symptom - Other
- Specify - Low reticulocyte count
- Symptom - Leukopenia
- Specify - Lymphopenia
- Symptom - Blood urea nitrogen decreased
- Symptom - Other
- Specify - Hyperglobulinemia
- Renal System
- Symptom - Other
- Specify - Bilateral renal pelvis dilation
- Nervous and Muscular Systems
- Renal System
- Symptom - Urinary incontinence
12. How long did the symptoms last?
Unknown / Inconnu
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?
Unknown
15. Outcome of the incident
Not recovered / Non rétabli
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 26-Feb-2024, an unknown time after application, the 0.33 year old, 2.11 kilograms, intact male, domestic short hair, cat with fleas, became lethargic, anorexic, ataxic, and was unable to stand. On 29-Feb-2024 the cat was seen by the veterinarian and found to have urinary incontinence, tachycardia (232bpm), hyperthermia (39.8 degrees celcius), prolapsed nictatating membranes, was trembling, and dehydrated. The cat was hospitalized and given subcutaneous fluids, 0.21ml of Maropitant intravenously and prescribed oral Maropitant, oral Meloxicam, Capstar, and transdermal Mertazapine. Blood tests were performed and the results showed, eosinopenia, low reticulocytes, lymphopenia, decreased BUN, and a slight hyperglobulinemia . An ultrasound showed bilateral dilation of the renal pelvis (coded as abnormal ultrasound finding).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here