Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-6374
2. Registrant Information.
Registrant Reference Number: 2013CK040
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.
21-OCT-13
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
13-AUG-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 (unspecified)
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
PMRA Registration No.
PMRA Submission No.
EPA Registration No.
Product Name: Boric acid
- Active Ingredient(s)
- BORACIC ACID (BORIC ACID)
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 an unknown date in April 2013, a 7 year old, 8 pound, spayed, female, Maine Coon Cat feline, in fair condition, with a concomitant medical condition of fleas, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) once topically 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
Maine coon
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
7
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
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- Nervous and Muscular Systems
- Gastrointestinal System
- Symptom - Salivating excessively
- Symptom - Anorexia
- Symptom - Weight loss
- Nervous and Muscular Systems
- Symptom - Abnormal posture
- Specify - could not lift its head up
- Respiratory System
- Symptom - Laboured breathing
- Specify - agonal
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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-Aug-2013, the corners of the house were sprinkled with boric acid, and it was accidentally spilt on the bed and the cat may have had contact with. On 13-Aug-2013, the cat was ataxic and lethargic. On 15-Aug-2013, the cat was hypersalivating, could not its lift head, non-ambulatory, and had weight loss. The cat was put in front of its water dish, to see if it was thirsty. The cat became agonal and died. No necropsy was performed. The call received was to discuss flea infestation, not to report this event.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The information regarding the death of the cat was casually provided during an inquiry. Obviously the owner did not assumed product involvement. Death occurred 4 months after last product exposure and thus was considered unlikely product related due to the inconsistent chronology. Signs which developed before the cat died were most likely related to other etiologies, eg contact with boric acid or due to other underlying medical problems. But a product relation can be excluded