Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-2239
2. Registrant Information.
Registrant Reference Number: 2017KP178
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.
19-APR-17
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
05-FEB-17
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. 11556-155
Product Name: Seresto Collar - Large Dog
- Active Ingredient(s)
- FLUMETHRIN
- IMIDACLOPRID
- Guarantee/concentration 10 %
7. b) Type of formulation.
Other (specify)
collar
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Other Units: collar
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 20-Apr-2016, a 12 year old, 25 pound, intact, male,Border Collie canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck 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
Other
2. Type of animal affected
Dog / Chien
3. Breed
Border Collie
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
25
lbs
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
>6 mos / > 6 mois
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Convulsions
- Symptom - Seizure
12. How long did the symptoms last?
Persisted until death
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 05Feb2017, the canine exhibited seizures and died. No necropsy was performed. No more information is expected and 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
This is off label use as collar was used for more than 8 months. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Collar has wide margin of safety. Even with oral product exposure, seizures are not expected. Merely gastrointestinal signs would be possible. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Moreover, involved animal is geriatric. Time to onset is exceptionally long (almost 9 months). Even though no necropsy was performed, considering all aspects and known safety profile of product, a product relation is deemed to be unlikely.