Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-3009
2. Registrant Information.
Registrant Reference Number: 2014CK231
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. 11556-125
Product Name: Advantage II medium dog
- 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.
1
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 unknown date in 2012, a 19 year old, 12 pound, neutered, male, Miniature Poodle canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Medium Dog (Imidacloprid-Pyriproxyfen) topically by the owner.
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
miniature poodle
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
19
7. Weight (provide a range if necessary )
12
lbs
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
12. How long did the symptoms last?
Persisted until death
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
An unspecified time after product administration the dog passed away. No necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The intent of the phone call to BAH was not to report the death of this patient but to inquire about the use of the product on another dog in the home. Reporting of occurence approximately 2 years after product application, thus occurrence of fatal outcome probably not within close time of product application. Nevertheless death is inconsistent with pharmaco-toxicological product profile and experience. 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. The cause of death of this geriatric dog is unknown according to case description. Product was used on animal before without causing any signs. The product continues to be used on other pets in the household and was not deemed responsible for the outcome of this patient. Finally, a product relation can be completely excluded.