Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-3849
2. Registrant Information.
Registrant Reference Number: 2015KP160
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.
02-NOV-13
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 - 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 25-Jun-2013, an 8 year old, 77 pound, spayed, female, Setter (English) canine, in fair condition with a congenital liver disorder treated with an unknown daily dose of s-adenosylmethionine/silybin phosphatidylcholine complex and fed a prescription diet, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around her 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
English Setter
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
77
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
- Nervous and Muscular Systems
12. How long did the symptoms last?
<=30 min / <=30 min
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 02Nov2013 the canine had a grand mal seizure and approximately 30 minutes later died. The owner took her to a veterinarian who determined she was dead on arrival. The owner declined necropsy and the canine was cremated. Follow-up information, 2013-02-07: 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. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration. No oral product exposure reported. Even with oral product exposure, seizures and subsequent death are not expected. Onset time not suggestive of product involvement either. The collar was worn without adverse signs for at least 4 months. Other causes (e.g. idiopathic epilepsy) are more likely. Dog was in fair condition with a congenital liver disorder treated with concurrent medications that may have contributed to signs. In the end, product involvement was considered unlikely.