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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-2996
2. Registrant Information.
Registrant Reference Number: 2014CK218
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.
17-JUL-145. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
Unknown
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 unknown
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- IMIDACLOPRID
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 2008, a 24 year old, Unknown weight, neutered, male, Domestic Shorthair feline, in unknown condition with no known concomitant medical conditions, was administered 1 dose of Advantage (cat-unspecified) (Imidacloprid) 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
domestic short hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
24
7. Weight (provide a range if necessary )
Unknown
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Lethargy
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
Approximately 2 hours post application the cat was lethargic. On an unknown date post application, in 2008, the cat died of unknown causes. It is unknown if a necropsy was performed.The reason for the initial call was to discuss the use on current pet and not to report the death of this patient.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Though lethargy is an unspecific sign and may have multiple potential other causes in an animal, it may represent a behavioural response to the product sensation. The information regarding the death of the cat was casually provided during an inquiry. The level of information is extremely low. Nevertheless 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. The reason for the initial call was to discuss the use on current pet and not to report the death of this patient. The cat was advanced in age and could have had other health conditions that contributed to the end result. Unknown if necropsy performed. Overall, product relation was unlikely.
