Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-1616
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0008817 (Report 474710)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
16-MAR-18
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: advantageII extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Other (specify)
spot-on
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 2017, an 85 pound, female, Unknown Breed canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Extra Large 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
Unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
38.555
kg
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?
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 unspecified date in Nov2017, post application the dog died. It is unknown if a necropsy was performed or if medical intervention was sought. No further 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
N - Unlikely - Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold over dosage was tolerated by dogs without showing any side effect. No signs of allergic/anaphylactic reaction reported. Other causes are more probable. Moreover, the information regarding the death of the dog was casually provided during an inquiry as the caller contacted Bayer Animal Health to inquire about use of the product on their pet and not to report death. Overall, even though low level of information is provided (e.g. Time to onset), considering the safety profile of the product and unexpected fatal outcome, a product relation is considered unlikely.