Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-1512
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2020-US0015544 (Report 630271)
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.
21-APR-20
5. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
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. Unknown
Product Name: advantageII pipette size unknown
- 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.
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).
On an unspecified date in 2010, two, 6 week old, Dachshund (Miniature) canines, in unknown condition, with no known concomitant medical conditions, were secondarily exposed to an unknown amount of Advantage (dog-unspecified) (Imidacloprid) that was applied topically to the lactating mother. This product is not labeled for use on lactating dogs.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Miniature Dachshund
4. Number of animals affected
2
5. Sex
Unknown
6. Age (provide a range if necessary )
0.115
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
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?
Contact treat.area/Contact surf. traitée
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Approximately 1 day post exposure, in 2010, the puppies had seizures and died. No necropsy was performed.
No more 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
Off label use as product applied on lactating mother. Seizure and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to seizure and death. The product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Unknown if product exposure occurred to puppies via mother. Studies on pregnant and lactating animals together with their offspring are limited. However due to limited information (health status, necropsy report) and short time to onset, relation to case was considered to be unassessable.