Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-2994
2. Registrant Information.
Registrant Reference Number: 2014CK216
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-14
5. 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. 11556-130
Product Name: Advantage 100
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
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 an unspecified date in 2013, an 11 year old, unknown weight, female, Australian Shepherd/ Border Collie Crossbreed canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage 100 Topical Solution (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
Dog / Chien
3. Breed
crossbreed dog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
11
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
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Neoplasia
12. How long did the symptoms last?
Persisted until death
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 an unspecified date the dog was diagnosed with a cardiac tumor. At an unknown time later the dog died. It is unknown if a necropsy was performed.The owner initially contacted Bayer Animal Health to seek advice on expiration of the product and not to report the death of this pet.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Reprted sign (such as cardiac neoplasm) is not expected after product application. sign is not consistent with pharmacol-toxicological product profile. Death not expected after product application, as inconsistent with pharmacotoxicological product profile. Death rather associated with the diagnosed cardiac tumour. No signs of allergy/anaphylactic reaction reported. The owner initially contacted Bayer Animal Health to seek advice on expiration of the product and not to report the death of this pet and thus did not suspect product involvement on signs and outcome either. Time to onset unknown. But considering all provided data, product relation considered to be rather unlikely.