Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-3786
2. Registrant Information.
Registrant Reference Number: 2015CK267
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.
12-MAR-15
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 -large 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 01-Jan-2015, a 12 year old, approximately 51.5 pound, female, Collie crossbred canine, of unknown reproductive status, in good condition, with no known concomitant medical conditions, had 1 Seresto Large Dog Collar (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?
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
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
51.5
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
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
- Respiratory System
- Symptom - Respiratory distress
- Blood
- Symptom - Other
- Specify - splenomegaly
- General
- Symptom - Malaise
- Specify - general illness
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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?
24
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 approximately 12-Mar-2015, the dog had unspecified clinical signs and presented to a veterinarian. The dog was diagnosed with an splenomegaly, hospitalized, and the spleen was surgically removed using unknown anesthetics.On approximately 13-Mar-2015, the dog had respiratory distress while hospitalized and died. No known necropsy was performed.The reason for the initial call was to discuss ticks and not to report the death of the patient.
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 signs are not expected after appropriate product application. Dog had undergone a surgery due to splenomegaly and developed respiratory distress afterwards and died. The intention of the call was not to report this event but to discuss other issue (ticks). Considering all aspects and rather late time to onset, a product relation can be ruled out.