Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-3251
2. Registrant Information.
Registrant Reference Number: 2013AM156
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.
13-JUN-13
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
22-OCT-11
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
- 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.
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).
One vial of Advantage II was applied topically by the owner to one spot on the dorsal midline.
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
Unknown
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Lethargy
- Symptom - Vocalizing
- Symptom - Hiding
- Nervous and Muscular Systems
12. How long did the symptoms last?
Unknown / Inconnu
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
Owner reports his cat was lethargic and vocalizing from a heavy flea infestation. Caller bathed cat with Hartz Flea and Tick shampoo on 10-22-11. The caller then placed cat in carrier and put in his car while he set off flea bombs in house and took laundry to laundromat. Caller returned home, applied product to cat and within 2 minutes the cat was hiding behind door, then vocalized, had a siezure and died. Caller reports no exam/necropsy were performed. No further information expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Serious nervous system disorders such as seizures and fatal outcome not anticipated with topical use of Advantage, as inconsistent with its pharmaco-toxicological profile. Cat heavily infested with fleas. Flea and tick shamppo used on cat which may contain pyrethroids. Furthermore containment stress and household flea bomb may have aggrevated situation. No signs of allergic /anaphalyctic reaction nor oral ingestion of Advantage reported. Time to onset too short for an product resorption. Even though no necropsy result available, overall, connection with Advantage considered unlikely. More probably effect of other applied products or underlying medical problem.