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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2022-0675
2. Registrant Information.
Registrant Reference Number: USA-ZZELANCO-US2021_026237
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.
21-SEP-215. Location of incident.
Country: UNITED STATES
Prov / State: PENNSYLVANIA
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. Unknown
Product Name: Advantage II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
- IMIDACLOPRID
PMRA Registration No. PMRA Submission No. EPA Registration No.
Product Name: TOPICAL ADAMS FLEA MEDICATION (UNSPECIFIED FORMULATION)
- Active Ingredient(s)
7. b) Type of formulation.
Liquid
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 21 Sep 2021, Elanco was contacted regarding adverse event in canine. On an unknown date in 2018, a dog had 1 tube of Advantage II pipette size unknown (Imidacloprid, Pyriproxyfen) applied topically. On an unknown date in approximately 2018, the Advantage II was out of stock and the owner instead applied 1 tube of unspecified topical Adams flea medication.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
Golden Retriever
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Lameness
- Symptom - Difficulty walking
- Symptom - Recumbent
- Symptom - Other
- Specify - Stroke
- General
- Symptom - Death
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?
5
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
Approximately 24 hours post application of the Adams topical flea medication, the 7 year old, Golden Retriever, in unknown condition, with no known concomitant medical conditions, exhibited lameness in 1 limb, and was unable to rise, or walk. The canine was evaluated by a veterinarian, diagnosed with a neurological stroke, and was hospitalized for 5 days. It was unknown what treatments were performed. On an unknown date in 2018, the canine was discharged to the care of the owner and was unable to walk without assistance. Approximately 1 month post application of the Adams flea medication the canine died. No known necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
