Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0693
2. Registrant Information.
Registrant Reference Number: 2017KP014
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.
27-JAN-17
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
11-SEP-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. 11556-151
Product Name: advantage II small cat
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Liquid
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 04-Sep-2016, a 2.5 year old, approximately 7.5 pound,neutered, female, Domestic Longhair feline, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the 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
Other
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Longhair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2.5
7. Weight (provide a range if necessary )
7.5
lbs
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
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Hiding
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
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 11-Sep-2016, the feline was hiding, anorexic, adipisic, and vomited. The feline died on the way to the veterinary clinic, approximately 1 hour post onset of signs. No necropsy was performed. The communication was not to report this event, but to discuss a flea efficacy. 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
Reported vomiting is not expected with appropriate topical product use. No oral exposure reported. Even with oral exposure sign is not expected. Systemic disorder and hiding is unspecific and may have numerous other causes. Further the information regarding the death of the cat was casually provided during an inquiry. Nevertheless death is inconsistent with pharmacotoxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Further the product was reported to be used on the feline for a period of time with no issues. Though no necropsy was performed and health status of animal is unknown, considering known safety profile of the product and long time to onset, a product relation is deemed to be unlikely.