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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-3822
2. Registrant Information.
Registrant Reference Number: 2015KP176
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-155. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
20-APR-14Product 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 - unknown
- Active Ingredient(s)
- Flumethrin
- IMIDACLOPRID
- Guarantee/concentration 10 %
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 20-Apr-2014, a 9 year old, 8.70 pound, neutered, female, Pomeranian canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog collar (unspecified) (Flumethrin-Imidacloprid) 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?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Dog / Chien
3. Breed
Pomeranian
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
8.70
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>2 hrs <=8 hrs / >2 h <=8 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- General
- Symptom - Death
- Nervous and Muscular Systems
- Symptom - Bizarre behaviour
- Gastrointestinal System
- Symptom - Anorexia
- General
- Symptom - Lethargy
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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
Approximately 3 hours post application the owner noticed an unspecified change in the dogs behavior. The collar was removed from the dog. The dog became anorexic and lethargic. On 27Apr2014 the dog presented to the veterinarian with history of 7 days of anorexia and the dog died. No necropsy was performed. No further information is expected; 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
N - Unlikely. Death is not expected after topical product use. Even not after oral product exposure. Time to onset not suggestive either, as death occured one week after collar was removed. In this case, death rather associated with anorexia lasting for one week, especially in a small breed dog with low weight. Anorexia, lethargy and behavioural changes however are unspecific signs and may have numerous other causes in an animal. Even though, time to onset short, unusual as signs persisted even days after collar was removed. In this case, state of health of treated animal prior to collar application unknown. Overall, product involvement rather unlikely.
