Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-6276
2. Registrant Information.
Registrant Reference Number: 2013CK024
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.
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. 11556-127
Product Name: Advantage II Large 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.
2.5
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 a 12.5 year old, spayed, female, Siberian Husky canine, in unknown condition, with no known concurrent medical conditions, was administered 1 tube of Advantage II Large Dog (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
Siberian husky
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12.5
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
- Gastrointestinal System
- Symptom - Bloating
- Symptom - Loss of appetite
- Blood
- Symptom - Hypoproteinemia
- Renal System
- Symptom - Other
- Specify - cyst
- Gastrointestinal System
- Symptom - Other
- Specify - fluid in abdomen
- Liver
- Symptom - Other
- Specify - abnormality
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
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 date post administration the dog exhibited not eating, not drinking, lethargy, and bloat. The dog was seen by a veterinarian. Diagnostics were performed as follows: Blood work- low protein, ultrasound- liver abnormality and cyst on kidney. Fluid was removed from the dog's abdomen. Other treatments are unknown. The dog passed away at an unknown time post treatment. 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
Described signs not expected, as inconsistent with product's pharmaco-toxicological profile. Signs reported more likely associated with the hepatic and renal disorder, which were diagnosed before the dog died. Also death is unlikely product-related as inconsistent with the pharmacotoxicological product profile. Unknown exposure date, unknown time to onset after product application, however, occurrence of fatal outcome probably not within close time of product application. 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. Cause of death probably due to underlying disease and old age according to case description. Therefore a product relation is considered unlikely.