Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-6922
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2017-US0057681(Report 444315)
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.
05-SEP-17
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. 11556-155
Product Name: Seresto Collar Small
- 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 approximately Dec 2015, a 17 year old, feline, of unknown signalment and condition, with no known concomitant medical conditions, had one Seresto Cat (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
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
unknown
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
17
7. Weight (provide a range if necessary )
Unknown
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 - Death
- Symptom - Other
- Specify - Abdominal mass
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Unknown
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 unspecified date, in approximately Aug 2016, the collar was removed.
On an unknown date, in Dec 2016, the feline exhibited a tumor in the abdomen and then died; no known necropsy was 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
Abdominal tumor and death are not expected following appropriate topical product application as inconsistent with products 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. Cat involved in this case was geriatric as well. Death may be the likely consequence of diagnosed tumor in abdomen. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Time to onset is too long. Overall even though necropsy result and medical history is unknown, sufficient information exists to rule out product involvement, hence a product association is unlikely.