Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-4932
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2017-US0041588
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
10-JUL-17
5. Location of incident.
Country: UNITED STATES
Prov / State: KANSAS
6. Date incident was first observed.
03-OCT-16
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. 11556-150
Product Name: Advantage II Kitten
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXIFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Other (specify)
Spot-on
Application Information
8. Product was applied?
Yes
9. Application Rate.
.23
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).
A 17 year old, 4 pound, neutered, female, cat, of unknown breed and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Kitten (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
17
7. Weight (provide a range if necessary )
1.814
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Abnormal gait
- Specify - Gait abnormality
- Symptom - Head tilt
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
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 01-Oct-2016, a 17 year old, 4 pound, neutered, female, cat, of unknown breed and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Kitten (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner.
On approximately 03-Oct-2016, the cat exhibited a gait abnormality and a head tilt. The cat was examined by a veterinarian and it is unknown what, if any treatment beyond observation was performed.
On approximately 01-Nov-2016, the cat died. No known necropsy was performed.
No further information is expected. This case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Gait abnormality is neither expected nor inline with products pharmaco-toxicological profile. Head tilt is not typically observed with appropriate topical product administration. An appropriate dosage was applied and no oral product exposure reported. Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Time to onset is long. The cat likely died due old age. Finally, even though some information is missing (e.g. necropsy details), considering known product safety profile, product relation is unlikely.