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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-3621
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2021-US0027044 (Report 708992)
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.
22-JUN-215. Location of incident.
Country: UNITED STATES
Prov / State: ALABAMA
6. Date incident was first observed.
10-JUN-21Product 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. 11556-144
Product Name: K9advantixII extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
- IMIDACLOPRID
7. b) Type of formulation.
Other (specify)
Spot-onApplication Information
8. Product was applied?
Yes
9. Application Rate.
4Units: 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 approximately 08-Jun-2021, a 12 year old, of unknown weight, female, Shepherd Dog - German dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Over 55 lbs) (Imidacloprid-Permethrin-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
German Shepherd Dog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- General
- Symptom - Death
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 approximately 10-Jun-2021, the dog developed generalized alopecia. On approximately 12-Jun-2021, the dog died. No necropsy was performed. 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 alopecia on other sites than the application site is not typically seen. If any, sign would be localized at the application site. Sign may represent a sensitivity reaction to the product, but other causes should also be considered (e.g. allergies). Death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Time to onset is long. Other causes must be considered in this geriatric animal. Limited information is available (necropsy report, medical history, health status of animal). Overall, considering all aspects, a product relation is unassessable.
