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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-6119
2. Registrant Information.
Registrant Reference Number: 2015KP238
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Mississauga
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.
19-OCT-155. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
01-JUL-15Product 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 %
- IMIDACLOPRID
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4Units: 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-Jun-2015, a 16 year old, 8.5 pound, intact, female, Persian feline, in good condition, with concomitant 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?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Cat / Chat
3. Breed
Persian
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
16
7. Weight (provide a range if necessary )
8.5
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
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
- General
- Symptom - Death
- Skin
- Symptom - Pruritus
- Gastrointestinal System
- Symptom - Anorexia
12. How long did the symptoms last?
Unknown / Inconnu
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 01-Jul-2015, the cat developed generalized pruritus. On 04-Jul-2015, the cat was administered Advantage II again. On 05-Jul-2015, the cat became anorexic. On 06-Jul-2015, the cat died at home. A necropsy examination was not 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
Generalized pruritus is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Anorexia is unspecific and may have various other causes. Death is inconsistent with pharmaco-toxicological 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. Reported time to onset for death of 2 days is not suggestive of product involvement. Previous applications tolerated quite well. Other causes must be considered in this old age cat however, a necropsy examination was not performed. Finally, considering all aspects a product relation remains unassessable.
