Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-3768
2. Registrant Information.
Registrant Reference Number: 2015CK249
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Boulevard
City: Missisaugua
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.
05-AUG-15
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
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. 1556-155
Product Name: Seresto Collar - small 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 an unknown date in Jul-2014, a 14 year old, 9 pound, neutered, female, Maltese/Poodle (Miniature) crossbred canine, in poor condition, with anorexia, lethargy and unspecified metastatic disease, had 1 Seresto Small 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
cross
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
14
7. Weight (provide a range if necessary )
9
lbs
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
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
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 an unknown date in Nov-2014, the dog died. No necropsy was performed.Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought.
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 products pharmacological profile. Oral exposure to the collar is not expected to cause death either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. No necropsy was performed. Death was prabably the consequence of concomitant unspecified metastatic disease and thus, sufficient information exists to rule out product involvement.Time to onset of more than 3 months is quite long. Finally, the product relation is considered as unlikely.