Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-6381
2. Registrant Information.
Registrant Reference Number: 2013CK047
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.
30-JAN-12
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 %
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 18-Jan-2012, a 17 year old, Unknown weight, neutered, male, Mixed Breed canine, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Advantage II (dog-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
Dog / Chien
3. Breed
Cross Breed
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
17
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Neoplasia
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
On an unknown period of time after application the dog was diagnosed with a tumor on his spleen. On 30 Jan 2012 the dog died at home. No necropsy was performed. No more information is expected. This case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Neoplasia of the spleen resulting in death is not expected, as inconsistent with pharmaco-toxicological product profile and experience. Product is only topically acting and has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. No reaction on previous exposure. Clinical sign diagnosed at an unknown time after last product exposure but within 30 days. The dog probably died due to underlying medical condition of neoplasia of the spleen according to case narrative in this old dog. Finally, a product relation can be excluded.