Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-4577
2. Registrant Information.
Registrant Reference Number: 2013AM194
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-AUG-13
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
Product Name: Advantage II (unknown size)
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PYRIPROXYFEN
- Guarantee/concentration 44 %
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
Dog / Chien
3. Breed
Dalmation
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
14
7. Weight (provide a range if necessary )
64
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Other
- Specify - arthritis
- Symptom - Other
- Specify - lupus
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 approximately 01-Nov-2012, a 14 year old, 64 pound, spayed, female, Dalmation canine, in unknown condition with no known concurrent medical conditions, was administered 1 tube of Advantage II (unspecified) (Imidacloprid-Pyriproxyfen) once topically by the owner. The pet owner does not apply product in winter months. On an unknown date the dog exhibited an arthritic condition and was later diagnosed with lupus. The dog was treated with acupuncture but later died in March 2012. No necropsy was performed. No more information is expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Intended direct topical dermal exposure of the product to the dog. Exposed site is inconsistent with affected site. Diagnosed Lupus and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg / kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Other underlying causes for death of this geriatric dog unknown according to case description. Duration to onset of signs too long. Chronology inconsistent. Therefore a product relation is considered unlikely.