Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-0394
2. Registrant Information.
Registrant Reference Number: 2014CK018
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
16-JAN-14
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
08-OCT-13
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 cat (unspecified)
- 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.
.8
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 approximately 31-Aug-2012, a 5 month old, unknown weight, spayed, female, Domestic Shorthair feline, in good condition, with no known concomitant medical condition, had Advantage Multi Cats (unspecified) (moxidectin-imidacloprid) and Advantage II cat (unspecified) (imidacloprid-pyryproxyfen) unknow dose applied.On 31 Aug 2013 the cat was now 19 month old and 8 pound, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner.
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
Cat / Chat
3. Breed
domestic short hair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.75
7. Weight (provide a range if necessary )
8
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
- Symptom - Swelling
12. How long did the symptoms last?
<=30 min / <=30 min
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 08 Oct 2013 the collar got stuck in the cat's jaw and on an unknown period of time later the cat had mouth bleeding, had facial swelling and lacerations/skin lesions on the face. The collar was removed by the owner and the cat died of unknown causes after 30 minutes. No necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Reported signs and fatal out come are not expected as not in line with pharmaco-toxicological product profile. Very long time to onset ( 1 year) excludes a product relation. Inspite of no necropsy was performed, product relation can be excluded