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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2277
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0023236 (Report 487756)
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.
22-MAY-185. Location of incident.
Country: UNITED STATES
Prov / State: NEW YORK
6. Date incident was first observed.
19-MAY-18Product 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 %
- FLUMETHRIN
7. b) Type of formulation.
Other (specify)
COLLARApplication Information
8. Product was applied?
Yes
9. Application Rate.
1Other 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 approximately 15-Apr-2018, a 4 year old, female cat, of unknown signalment and condition, with no known concomitant medical conditions who lived indoors and outdoors, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
unknown
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
4
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
- General
- Symptom - Death
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 19-May-2018, the cat was hit by a car and died. No known necropsy was performed. No further information is expected. This case is closed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the perceived lack of efficacy of the product on another animal and not to report the death in this event.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Outcome was the consequence of alternative cause of hit by a car. Furthermore the initial call was to discuss the perceived lack of efficacy of the product on another animal and not to report the death in this event. Time to onset is long. Thus sufficient information exists to rule out product involvement. Overall, a product relation is unlikely.
