Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2267
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0021964 (Report 487198)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
18-MAY-18
5. Location of incident.
Country: UNITED STATES
Prov / State: KANSAS
6. Date incident was first observed.
14-MAY-18
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 Cat
- Active Ingredient(s)
- FLUMETHRIN
- Guarantee/concentration 4.5 %
- 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 20Oct2017, a 2.5 year old, 13.6 pound, neutered, male, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around his 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
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2.5
7. Weight (provide a range if necessary )
6.169
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>6 mos <=1 yr / > 6 mois < = 1 an
10. Time between exposure and onset of symptoms
>6 mos / > 6 mois
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- General
- Symptom - Adipsia
- Symptom - Lethargy
- Renal System
- Symptom - Inappropriate urination
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
12
Hour(s) / Heure(s)
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 14May2018, the feline exhibited an abnormal behavior.
On 17May2018, the feline was anorexic, adipsic, lethargic, and urinated on himself. He was taken to the veterinary clinic and started on unspecified fluid therapy, received an unknown dose of Heparin by an unknown route, received an unknown dose of Azithromycin by an unknown route and was hospitalized.
Approximately 12 hours post hospitalization, the feline passed away. A necropsy was not performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Reported behavioural and systemic disorders are unspecific signs and may have numerous other causes. Signs started more than a half year after product application and uneventful use of the product. Reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. Time to onset long. Collar was well tolerated for almost 6 months after application. Finally, a product connection is considered to be unlikely.