Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-2848
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2020-US0031926 (Report 648161)
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.
30-JUN-20
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: advantageII 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.
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 in approximately 2018, a 15 year old, female, Poodle (Unspecified)/Retriever - Labrador crossbred dog, of unknown weight and reproductive status, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) via the topical route by the animal 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
Crossbred (Poodle (Unspecified) x Retriever - Labrador)
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
15
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
- Cardiovascular System
- Symptom - Other
- Specify - Cardiac disorder NOS
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
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 post application, in approximately Jun-2018, the dog developed a cardiac disorder.
On 25-Dec-2019, the dog died.
No necropsy was performed.
The intent of the call was to inquire about product use in general and not to report this event.
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
O - Unclassifiable/unassessable
Reported cardiac disorder is not expected after product application. Other causes must be considered. Time to onset is unknown. Further reported death is not expected either, as inconsistent with pharmaco-toxicological product profile. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. In this case, the intent of the call was to inquire about product use in general and not to report this event. Time to onset is long. Considering overall aspects, a product relation for the case is unassessable.